Vascular Access DevicesNCT07791875
AI-Based Analysis of Port Catheter Tip Position
An observational study of Vascular Access Devices, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Devices
- What is being tested?
- AI-Based Automated Image Analysis and Manual A+B Measurement Method
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older scheduled for right internal jugular vein placement of a totally implantable venous access port at Bagcilar Training and Research Hospital will be screened consecutively for this single-center prospective observational study. Enrollment will require written informed consent and confirmation of all eligibility criteria, including availability of a clinically indicated post-implantation noncontrast chest computed tomography (CT) examination and absence of documented catheter manipulation or revision before the selected CT. CT reference evaluability and generation of a valid automated output will determine the relevant analysis populations and will not be prerequisites for enrollment. No additional imaging will be performed for research purposes.
Who may be able to join
- Age 18 years or older.
- Planned placement of a totally implantable venous access port through the right internal jugular vein as part of routine clinical care.
- Availability of a suitable pre-implantation chest radiograph obtained as part of routine clinical care.
- Availability of a clinically indicated post-implantation noncontrast chest computed tomography examination.
- Absence of documented catheter manipulation or revision before the selected post-implantation computed tomography examination.
- Provision of written informed consent.
Who cannot join
- Age younger than 18 years.
- Cancellation of the routine clinical port implantation plan.
- Planned or performed port placement through a venous access route other than the right internal jugular vein.
- No suitable pre-implantation chest radiograph available for study assessment.
- Advanced thoracic deformity or mediastinal distortion precluding the required study measurements.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Bağcılar, Istanbul, 34200
Serdar Demirgan, +90 212 440 40 00, istanbuleah30@saglik.gov.tr
About this study
Official title: Determination of Port Catheter Tip Position Using Artificial Intelligence-Based Automated Image Analysis
This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.
Read the detailed description
Before prospective enrollment, a two-dimensional nnU-Net-based multitask model will be developed and internally tested using retrospective chest radiographs from the same center. The model parameters, ensemble, preprocessing steps, and technical output rules will be locked before prospective enrollment. The retrospective development and internal test datasets are not part of the enrollment reported for this record.
The prospective component will include one observational cohort of adults aged 18 years or older undergoing right internal jugular vein port implantation during routine clinical care. Implantation, chest radiography, computed tomography, and all clinical management decisions will remain under the responsibility of the treating clinical team and will not be assigned by the research protocol. The automated output will not be made available for procedural guidance or patient management.
For each evaluable participant, the locked automated method will generate an estimate based on chest radiographic image analysis and a patient-specific Delta adjustment. A prespecified manual A+B measurement method will be applied as a comparator in the same participants. Reference measurements will be derived from the first suitable post-implantation noncontrast chest computed tomography examination obtained for a routine clinical indication, provided that both the catheter tip and the cavoatrial junction are visible and no catheter manipulation occurred beforehand. No additional radiographic or computed tomography examination will be requested for the study.
The primary objective is to quantify the error of the automated estimate using mean absolute error in the prospective cohort. Prespecified secondary analyses will evaluate additional error, agreement, pragmatic accuracy, technical assessability, and repeatability measures. The ±10 mm criterion will be treated as a pragmatic accuracy threshold rather than a clinical safety boundary. The study is a same-center prospective performance evaluation; it is not an external validation and is not designed to assess clinical benefit or to establish that the system is ready for clinical use.
- Conditions
- Vascular Access Devices
- Being tested
- AI-Based Automated Image Analysis, Manual A+B Measurement Method
- Keywords
- Port Catheter, Deep Learning, Cavoatrial Junction, Chest Radiography, Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Automated Image AnalysisDiagnostic test
The locked automated method will use chest radiographic image analysis and a patient-specific Delta adjustment to estimate port catheter tip position. The method will be evaluated offline using reference measurements derived from clinically indicated post-implantation noncontrast chest computed tomography. Its output will not be provided to the clinical team and will not guide port implantation or alter clinical decisions.
Manual A+B Measurement MethodDiagnostic test
The prespecified manual A+B method will estimate port catheter tip position using manual measurements on the pre-implantation chest radiograph. It will be applied as a comparator in the same participants. The manual research measurement will not guide port implantation or alter clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Port Catheter Cohort | Adults aged 18 years or older undergoing totally implantable venous access port implantation through the right internal jugular vein as part of routine clinical care will be enrolled in a single prospective observational cohort. In each evaluable participant, the locked AI-based automated A+B+Delta method and the prespecified manual A+B measurement method will be assessed using reference measurements from clinically indicated post-implantation noncontrast chest computed tomography. No research-specific imaging will be performed, and the automated output will not guide port implantation or alter clinical decisions. Receives: Diagnostic Test: AI-Based Automated Image Analysis; Diagnostic Test: Manual A+B Measurement Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using 10,000 participant-level bias-corrected and accelerated bootstrap resamples.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Secondary outcomes (20)
Median Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Median absolute error (MedAE), in millimeters, will be calculated as the median of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Root mean squared error (RMSE), in millimeters, will be calculated as the square root of the arithmetic mean of the squared differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller overall estimation error, and larger individual errors have greater influence because differences are squared before averaging. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Mean signed error, in millimeters, will be calculated as the arithmetic mean of the catheter advancement length estimated by the locked AI-based automated A+B+Delta method minus the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Positive values indicate that the automated method estimates a longer advancement length than the reference, negative values indicate a shorter estimate, and zero indicates no average directional error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Paired Difference in Absolute Error Between the AI-Based Automated A+B+Delta and Manual A+B Methods
For each participant, absolute error will be calculated for both the locked AI-based automated A+B+Delta method and the manual A+B method relative to the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The paired difference, in millimeters, will be calculated as automated absolute error minus manual absolute error, and its arithmetic mean will be reported. The analysis population will include participants with an evaluable reference measurement and valid estimates from both methods. Negative values indicate a smaller absolute error for the automated method, positive values indicate a smaller absolute error for the manual method, and zero indicates no average paired difference. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm
The proportion of evaluable participants whose absolute error is 10 mm or less will be calculated for the locked AI-based automated A+B+Delta method. Absolute error will be defined as the absolute difference between the automated estimate and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The denominator will include participants with both a valid automated output and an evaluable reference measurement, and the result will be reported as a percentage with a 95% Wilson score confidence interval. A higher percentage indicates that a larger proportion of estimates meet this prespecified pragmatic accuracy criterion. The 10 mm threshold is an operational technical accuracy criterion and not a clinical safety boundary.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Paired Difference in Proportions of Estimates With Absolute Error Within 10 mm Between the AI-Based Automated A+B+Delta and Manual A+B Methods
For each participant, the locked AI-based automated A+B+Delta estimate and the manual A+B estimate will each be classified by whether the absolute error from the reference catheter advancement length is 10 mm or less. The paired proportion difference, in percentage points, will be calculated as the automated qualifying proportion minus the manual qualifying proportion. The analysis population will include participants with an evaluable reference measurement and valid estimates from both methods. Positive values indicate a higher qualifying proportion for the automated method, and negative values indicate a higher qualifying proportion for the manual method. A 95% confidence interval will be calculated using Newcombe's method 10; an exact two-sided McNemar test will be used as an auxiliary analysis. The 10 mm threshold is a prespecified pragmatic accuracy criterion and not a clinical safety boundary.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Technical Success Rate of the AI-Based Automated A+B+Delta Method
Technical success will be defined as the generation of a valid numerical output by the AI-based automated A+B+Delta method after the method has been locked for prospective evaluation. The numerator will be the number of participants enrolled in the prospective cohort for whom the method generates a valid automated output, and the denominator will be all participants enrolled in the prospective cohort. A valid output requires the prespecified image-scale, anatomical-landmark, projection, image-quality, and uncertainty criteria to be satisfied. The result will be reported as a percentage with a 95% Wilson score confidence interval. Technical success will be reported separately from measurement accuracy among participants with evaluable reference data. A higher percentage indicates greater technical output availability and does not represent clinical effectiveness or safety.
Measured: At baseline, during offline analysis of the pre-implantation chest radiograph obtained before port implantation
Intraobserver Agreement of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance Assessed by ICC(A,1)
Intraobserver agreement of the computed tomography (CT)-derived catheter tip-to-cavoatrial junction distance (dBT) will be assessed using a two-way random-effects, absolute-agreement, single-measure intraclass correlation coefficient [ICC(A,1)]. The same radiologist will repeat the dBT measurement in a prespecified random subset of 60 cases after a 4-week washout period, using newly assigned identifiers and reshuffled images while blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. Higher ICC values indicate greater relative agreement. The estimate will be reported with a 95% confidence interval.
Measured: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Mean Intraobserver Difference in the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
The mean signed difference (second reading minus first reading), in millimeters, will be calculated for the computed tomography-derived catheter tip-to-cavoatrial junction distance in the prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout period. The radiologist will use newly assigned identifiers and reshuffled images and will be blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. Positive values indicate a larger measurement at the second reading, negative values indicate a smaller measurement, and values closer to zero indicate less average systematic difference. A 95% confidence interval will be reported.
Measured: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Within-Subject Standard Deviation of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Within-subject standard deviation (wSD), in millimeters, will quantify within-observer variation in the computed tomography-derived catheter tip-to-cavoatrial junction distance. In the prespecified random subset of 60 cases, the same radiologist will repeat the measurement after a 4-week washout period using newly assigned identifiers and reshuffled images while blinded to the initial measurement. Only cases evaluable at both readings will be analyzed. For these cases, wSD will be calculated as the standard deviation of the paired differences (second reading minus first reading) divided by the square root of 2. Lower values indicate less within-observer measurement variation. A chi-square-based 95% confidence interval will be reported.
Measured: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement for the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Bland-Altman limits of agreement (LoA), in millimeters, will be calculated for the CT-derived catheter tip-to-cavoatrial junction distance in a prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout. Paired differences will be the second reading minus the first. The mean difference and LoA (mean difference +/- 1.96 times the standard deviation of paired differences) will be reported. Only cases evaluable at both readings will be analyzed. The radiologist will use new identifiers and reshuffled images while blinded to the initial measurement. The mean difference will have a t-based 95% confidence interval. Separate two-sided 95% confidence intervals for each LoA will be calculated using the exact noncentral t method, assuming normally distributed paired differences. Narrower limits indicate less within-observer measurement variation.
Measured: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Repeatability Coefficient of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
The repeatability coefficient (RC), in millimeters, will quantify within-observer repeatability of the computed tomography-derived catheter tip-to-cavoatrial junction distance in the prespecified random subset of 60 cases measured twice by the same radiologist after a 4-week washout period. Paired differences will be defined as the second reading minus the first reading. The RC will be calculated as 1.96 times the standard deviation of the paired differences. Only cases evaluable at both readings will be analyzed. The radiologist will use newly assigned identifiers and reshuffled images and will be blinded to the initial measurement. Lower RC values indicate less within-observer measurement variation. A chi-square-based 95% confidence interval will be reported.
Measured: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement Between the AI-Based Automated A+B+Delta Estimate and the CT-Derived Reference
For participants with a valid automated output and an evaluable CT-derived reference measurement, paired differences, in millimeters, will be defined as the catheter advancement length estimated by the locked AI-based automated A+B+Delta method minus the CT-derived reference catheter advancement length. The mean difference and lower and upper 95% limits of agreement (LoA), calculated as the mean difference +/- 1.96 times the standard deviation of paired differences, will be reported. The mean difference will have a t-based 95% confidence interval. Separate two-sided 95% confidence intervals for each LoA will be calculated using the exact noncentral t method, assuming normally distributed paired differences. Positive differences indicate longer automated estimates than the reference, and negative differences indicate shorter estimates. This analysis describes agreement and does not establish clinical interchangeability or safety.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method
Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Median Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method
Median absolute error (MedAE), in millimeters, will be calculated as the median of the absolute differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the Manual A+B Method
Root mean squared error (RMSE), in millimeters, will be calculated as the square root of the arithmetic mean of the squared differences between the catheter advancement length estimated by the prespecified manual A+B measurement method and the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Lower values indicate smaller overall estimation error, and larger individual errors have greater influence because differences are squared before averaging. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the Manual A+B Method
Mean signed error, in millimeters, will be calculated as the arithmetic mean of the catheter advancement length estimated by the prespecified manual A+B measurement method minus the CT-derived reference catheter advancement length. The analysis population will include participants with both a valid manual A+B estimate and an evaluable CT-derived reference measurement. Positive values indicate that the manual method estimates a longer advancement length than the reference, negative values indicate a shorter estimate, and zero indicates no average directional error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Bland-Altman Limits of Agreement Between the Manual A+B Estimate and the CT-Derived Reference
For participants with a valid manual A+B estimate and an evaluable CT-derived reference measurement, paired differences, in millimeters, will be defined as the catheter advancement length estimated by the prespecified manual A+B method minus the CT-derived reference catheter advancement length. The mean difference and lower and upper 95% limits of agreement (LoA), calculated as the mean difference +/- 1.96 times the standard deviation of paired differences, will be reported. The mean difference will have a t-based 95% confidence interval. Separate two-sided 95% confidence intervals for each LoA will be calculated using the exact noncentral t method, assuming normally distributed paired differences. Positive differences indicate longer manual estimates than the reference, and negative differences indicate shorter estimates. This analysis describes agreement and does not establish clinical interchangeability or safety.
Measured: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of the AI-Based Automated A+B+Delta Method Within 24 Hours After Port Implantation and Before Catheter Manipulation
In the prespecified sensitivity subset of participants whose first eligible post-implantation noncontrast chest computed tomography examination is obtained within 24 hours after port implantation and before any documented catheter manipulation, mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the CT-derived reference catheter advancement length. Only participants with a valid automated output and an evaluable CT-derived reference measurement will be included. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using participant-level bootstrap resampling.
Measured: Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm Within 24 Hours After Port Implantation and Before Catheter Manipulation
In the prespecified sensitivity subset of participants whose first eligible post-implantation noncontrast chest computed tomography examination is obtained within 24 hours after port implantation and before any documented catheter manipulation, the proportion of evaluable participants whose absolute error is 10 mm or less will be calculated for the locked AI-based automated A+B+Delta method. Absolute error will be defined as the absolute difference between the automated estimate and the CT-derived reference catheter advancement length. The denominator will include participants with both a valid automated output and an evaluable CT-derived reference measurement. The result will be reported as a percentage with a 95% Wilson score confidence interval. The 10 mm threshold is a prespecified pragmatic technical accuracy criterion and not a clinical safety boundary.
Measured: Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start5 Oct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791875
- Sponsor's protocol ID
- E-10840098-50.04-1975
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share de-identified individual participant data has not yet been finalized. Any future sharing decision will be subject to applicable ethics approval, participant consent, institutional policy, and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Port Catheter Tip Position Using Artificial Intelligence-Based Automated Image Analysis
- ClinicalTrials.gov ID
- NCT07791875
- Acronym / sponsor ID
- E-10840098-50.04-1975
- Conditions
- Vascular Access Devices
- Keywords
- Port Catheter, Deep Learning, Cavoatrial Junction, Chest Radiography, Computed Tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.
Detailed description
Before prospective enrollment, a two-dimensional nnU-Net-based multitask model will be developed and internally tested using retrospective chest radiographs from the same center. The model parameters, ensemble, preprocessing steps, and technical output rules will be locked before prospective enrollment. The retrospective development and internal test datasets are not part of the enrollment reported for this record.
The prospective component will include one observational cohort of adults aged 18 years or older undergoing right internal jugular vein port implantation during routine clinical care. Implantation, chest radiography, computed tomography, and all clinical management decisions will remain under the responsibility of the treating clinical team and will not be assigned by the research protocol. The automated output will not be made available for procedural guidance or patient management.
For each evaluable participant, the locked automated method will generate an estimate based on chest radiographic image analysis and a patient-specific Delta adjustment. A prespecified manual A+B measurement method will be applied as a comparator in the same participants. Reference measurements will be derived from the first suitable post-implantation noncontrast chest computed tomography examination obtained for a routine clinical indication, provided that both the catheter tip and the cavoatrial junction are visible and no catheter manipulation occurred beforehand. No additional radiographic or computed tomography examination will be requested for the study.
The primary objective is to quantify the error of the automated estimate using mean absolute error in the prospective cohort. Prespecified secondary analyses will evaluate additional error, agreement, pragmatic accuracy, technical assessability, and repeatability measures. The ±10 mm criterion will be treated as a pragmatic accuracy threshold rather than a clinical safety boundary. The study is a same-center prospective performance evaluation; it is not an external validation and is not designed to assess clinical benefit or to establish that the system is ready for clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Port Catheter Cohort | – | Diagnostic Test: AI-Based Automated Image Analysis, Diagnostic Test: Manual A+B Measurement MethodAdults aged 18 years or older undergoing totally implantable venous access port implantation through the right internal jugular vein as part of routine clinical care will be enrolled in a single prospective observational cohort. In each evaluable participant, the locked AI-based automated A+B+Delta method and the prespecified manual A+B measurement method will be assessed using reference measurements from clinically indicated post-implantation noncontrast chest computed tomography. No research-specific imaging will be performed, and the automated output will not guide port implantation or alter clinical decisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older scheduled for right internal jugular vein placement of a totally implantable venous access port at Bagcilar Training and Research Hospital will be screened consecutively for this single-center prospective observational study. Enrollment will require written informed consent and confirmation of all eligibility criteria, including availability of a clinically indicated post-implantation noncontrast chest computed tomography (CT) examination and absence of documented catheter manipulation or revision before the selected CT. CT reference evaluability and generation of a valid automated output will determine the relevant analysis populations and will not be prerequisites for enrollment. No additional imaging will be performed for research purposes.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Planned placement of a totally implantable venous access port through the right internal jugular vein as part of routine clinical care.
- Availability of a suitable pre-implantation chest radiograph obtained as part of routine clinical care.
- Availability of a clinically indicated post-implantation noncontrast chest computed tomography examination.
- Absence of documented catheter manipulation or revision before the selected post-implantation computed tomography examination.
Key exclusion criteria (6 listed)
- Age younger than 18 years.
- Cancellation of the routine clinical port implantation plan.
- Planned or performed port placement through a venous access route other than the right internal jugular vein.
- No suitable pre-implantation chest radiograph available for study assessment.
- Advanced thoracic deformity or mediastinal distortion precluding the required study measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Automated Image AnalysisThe locked automated method will use chest radiographic image analysis and a patient-specific Delta adjustment to estimate port catheter tip position. The method will be evaluated offline using reference measurements derived from clinically indicated post-implantation noncontrast chest computed tomography. Its output will not be provided to the clinical team and will not guide port implantation or alter clinical decisions. | Diagnostic test | Prospective Port Catheter Cohort |
| Manual A+B Measurement MethodThe prespecified manual A+B method will estimate port catheter tip position using manual measurements on the pre-implantation chest radiograph. It will be applied as a comparator in the same participants. The manual research measurement will not guide port implantation or alter clinical care. | Diagnostic test | Prospective Port Catheter Cohort |
Primary outcome
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean absolute error (MAE), in millimeters, will be calculated as the arithmetic mean of the absolute differences between the catheter advancement length estimated by the locked AI-based automated A+B+Delta method and the reference catheter advancement length derived from the first eligible post-implantation noncontrast chest computed tomography examination. The analysis population will include participants with both a valid automated output and an evaluable reference measurement. Lower values indicate smaller estimation error. A 95% confidence interval will be estimated using 10,000 participant-level bias-corrected and accelerated bootstrap resamples.
20 secondary outcomes
Median Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Paired Difference in Absolute Error Between the AI-Based Automated A+B+Delta and Manual A+B Methods
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Paired Difference in Proportions of Estimates With Absolute Error Within 10 mm Between the AI-Based Automated A+B+Delta and Manual A+B Methods
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Technical Success Rate of the AI-Based Automated A+B+Delta Method
Time frame: At baseline, during offline analysis of the pre-implantation chest radiograph obtained before port implantation
Intraobserver Agreement of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance Assessed by ICC(A,1)
Time frame: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Mean Intraobserver Difference in the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Time frame: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Within-Subject Standard Deviation of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Time frame: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement for the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Time frame: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Repeatability Coefficient of the CT-Derived Catheter Tip-to-Cavoatrial Junction Distance
Time frame: At repeat assessment of the CT-derived reference measurement after a 4-week washout period
Bland-Altman Limits of Agreement Between the AI-Based Automated A+B+Delta Estimate and the CT-Derived Reference
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Median Absolute Error of Catheter Advancement Length Estimated by the Manual A+B Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Root Mean Squared Error of Catheter Advancement Length Estimated by the Manual A+B Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Signed Error of Catheter Advancement Length Estimated by the Manual A+B Method
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Bland-Altman Limits of Agreement Between the Manual A+B Estimate and the CT-Derived Reference
Time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision
Mean Absolute Error of the AI-Based Automated A+B+Delta Method Within 24 Hours After Port Implantation and Before Catheter Manipulation
Time frame: Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care
Proportion of AI-Based Automated A+B+Delta Estimates With Absolute Error Within 10 mm Within 24 Hours After Port Implantation and Before Catheter Manipulation
Time frame: Within 24 hours after port implantation and before any documented catheter manipulation, at the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. The plan to share de-identified individual participant data has not yet been finalized. Any future sharing decision will be subject to applicable ethics approval, participant consent, institutional policy, and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Devices, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Balamir Utku Seker (+90 539 433 79 62, b.utku.seker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Error of Catheter Advancement Length Estimated by the AI-Based Automated A+B+Delta Method (time frame: At the first eligible post-implantation noncontrast chest computed tomography examination obtained during routine care, before any documented catheter manipulation or revision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.