Gastrointestinal LesionsPCCT-GINCT07748923
Photon-Counting CT for Detection of Small Gastrointestinal Lesions
An observational study of Gastrointestinal Lesions, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This comparative matched-cohort study aims to evaluate the diagnostic performance of contrast-enhanced photon-counting computed tomography (PCCT) for detecting small gastrointestinal lesions compared with energy-integrating detector dual-energy computed tomography (DECT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Lesions
- What is being tested?
- Contrast-Enhanced Photon-Counting Computed Tomography and Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography
- How many people
- 1,762 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2023to 21 May 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes two cohorts: a retrospective diagnostic-performance cohort and a prospective clinical implementation cohort. Patients underwent contrast-enhanced photon-counting CT (PCCT) or energy-integrating detector dual-energy CT (DECT) for evaluation of suspected small gastrointestinal lesions in a clinical setting.
Who may be able to join
- Adults aged 18-80 years.
- Patients undergoing contrast-enhanced abdominal CT (photon-counting CT or energy-integrating detector dual-energy CT).
- At least one endoscopically detected or clinically suspected small gastrointestinal lesion.
- Lesions confirmed or suspected on endoscopy, pathology, or follow-up imaging.
- Lesions characterized as mucosal thickening or nodular lesions within predefined size criteria (≤2 cm).
Who cannot join
- Prior gastrointestinal surgery affecting target evaluation region.
- Poor or nondiagnostic CT image quality.
- Incomplete or unavailable endoscopic or histopathological reference standard.
- Ambiguous lesion localization on endoscopy or imaging.
- Severe motion artifacts or inadequate bowel distension affecting diagnostic evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Photon-Counting CT for Detection of Small Gastrointestinal Lesions: Comparison With Energy-Integrating Detector Dual-Energy CT and Prospective Clinical Implementation
This comparative matched-cohort study aims to evaluate the diagnostic performance of contrast-enhanced photon-counting computed tomography (PCCT) for detecting small gastrointestinal lesions compared with energy-integrating detector dual-energy computed tomography (DECT). The study includes a prospectively enrolled PCCT cohort and a retrospectively identified DECT cohort. Endoscopy with histopathology serves as the reference standard. Primary evaluation focuses on lesion detection, with additional assessment of lesion characterization, image quality, quantitative imaging parameters, and interobserver agreement.
- Conditions
- Gastrointestinal Lesions
- Being tested
- Contrast-Enhanced Photon-Counting Computed Tomography, Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography
- Keywords
- Small Gastrointestinal Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced Photon-Counting Computed TomographyDiagnostic test
Also called PCCT
Contrast-enhanced abdominal photon-counting computed tomography performed for the detection and characterization of small gastrointestinal lesions.
Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed TomographyDiagnostic test
Also called DECT
Contrast-enhanced abdominal energy-integrating detector dual-energy computed tomography performed for comparison of diagnostic performance in detecting and characterizing small gastrointestinal lesions.
| Study group | Role | What they receive |
|---|---|---|
| PCCT Diagnostic Cohort | Prospectively enrolled adults who underwent contrast-enhanced photon-counting computed tomography (PCCT) for evaluation of suspected small gastrointestinal lesions. Patients meeting the eligibility criteria were included in the diagnostic performance cohort and subsequently matched 1:1 with the retrospective DECT cohort using propensity score matching. Receives: Diagnostic Test: Contrast-Enhanced Photon-Counting Computed Tomography | |
| DECT Diagnostic Cohort | Retrospectively identified adults who underwent contrast-enhanced energy-integrating detector dual-energy computed tomography (DECT) for evaluation of suspected small gastrointestinal lesions. Eligible patients were matched 1:1 with the prospective PCCT cohort using propensity score matching for diagnostic performance comparison. Receives: Diagnostic Test: Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography | |
| Prospective Clinical Implementation Cohort | Consecutive adults undergoing routine contrast-enhanced abdominal photon-counting computed tomography (PCCT) in clinical practice. Patients with CT-positive findings suggestive of small gastrointestinal lesions were referred for endoscopy when appropriate to evaluate the clinical implementation of PCCT. Receives: Diagnostic Test: Contrast-Enhanced Photon-Counting Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion-Based Detection Rate
Lesion-based detection rate of contrast-enhanced photon-counting CT compared with energy-integrating detector dual-energy CT using endoscopy with histopathology, when available, as the reference standard.
Measured: During the study period (January 2026 - March 2026)
Secondary outcomes (10)
Positive Predictive Value of CT-Positive Findings
Patient-level positive predictive value (PPV) of CT-positive findings for small gastrointestinal lesions detected on contrast-enhanced photon-counting CT (PCCT) in the prospective implementation cohort. Endoscopy with histopathology, when available, served as the reference standard.
Measured: During the study period (March 2026 to June 2026)
Yield of Clinically Actionable Lesions
Patient-level yield of clinically actionable small gastrointestinal lesions detected in consecutive patients undergoing routine contrast-enhanced photon-counting CT (PCCT) in clinical practice. Clinically actionable lesions were defined based on endoscopic or histopathological confirmation when available.
Measured: During the study period (March 2026 to June 2026)
Lesion-to-Mucosa Attenuation Difference
Difference in attenuation between gastrointestinal lesions and adjacent normal mucosa measured on 40-keV virtual monoenergetic images from photon-counting CT.
Measured: During the study period (January 2026 - March 2026)
Image Noise
Image noise will be defined as the standard deviation of CT attenuation values within a predefined region of interest in the target tissue or reference region. Image noise will be measured separately on photon-counting CT and dual-energy CT images. Lower values indicate lower image noise.
Measured: During the study period (January 2026 - March 2026)
Signal-to-Noise Ratio
The signal-to-noise ratio will be calculated as the mean CT attenuation value of the target tissue divided by image noise. SNR will be calculated separately for photon-counting CT and dual-energy CT images. Higher values indicate better signal relative to image noise.
Measured: During the study period (January 2026 - March 2026)
Contrast-to-Noise Ratio
The contrast-to-noise ratio will be calculated as the absolute difference between the mean CT attenuation values of the target tissue and the reference tissue divided by image noise. CNR will be calculated separately for photon-counting CT and dual-energy CT images. Higher values indicate greater contrast relative to image noise.
Measured: During the study period (January 2026 - March 2026)
Subjective Image Quality Score
Two radiologists, blinded to the clinical, endoscopic, and histopathologic findings, will independently evaluate the image quality of photon-counting CT and dual-energy CT images using a predefined 5-point ordinal scale. Scores range from 1 to 5, with higher scores indicating better subjective image quality.
Measured: During the study period (January 2026 - March 2026)
Interobserver Agreement for Lesion Detection
Agreement between two radiologists regarding the presence or absence of gastrointestinal lesions on CT images will be assessed using Cohen's kappa coefficient. Kappa values range from -1 to 1, with higher values indicating better interobserver agreement. Agreement will be evaluated separately for photon-counting CT and dual-energy CT.
Measured: During the study period (January 2026 - June 2026)
Interobserver Agreement for Lesion Size Measurement
Agreement between two radiologists for measurements of the maximal lesion diameter will be assessed using the intraclass correlation coefficient. Intraclass correlation coefficient values range from 0 to 1, with higher values indicating better interobserver agreement. Agreement will be evaluated separately for photon-counting CT and dual-energy CT.
Measured: During the study period (January 2026 - June 2026)
Interobserver Agreement for Diagnostic Confidence
Agreement between two radiologists for ordinal diagnostic confidence ratings will be assessed using the weighted kappa coefficient. Weighted kappa values range from -1 to 1, with higher values indicating better interobserver agreement. Agreement will be evaluated separately for photon-counting CT and dual-energy CT.
Measured: During the study period (January 2026 - March 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start18 Sep 2023
- Primary completion9 Jan 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal LesionsStudies 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
- Other
- Enrolment
- 1,762 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748923
- Sponsor's protocol ID
- 2026EC041
- Acronym
- PCCT-GI
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Individual data sharing
- No: This study is an observational diagnostic accuracy study based on routinely collected clinical imaging and endoscopic data. Individual participant data will not be publicly shared due to patient privacy protection and institutional data governance restrictions. Only aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photon-Counting CT for Detection of Small Gastrointestinal Lesions: Comparison With Energy-Integrating Detector Dual-Energy CT and Prospective Clinical Implementation
- ClinicalTrials.gov ID
- NCT07748923
- Acronym / sponsor ID
- PCCT-GI / 2026EC041
- Conditions
- Gastrointestinal Lesions
- Keywords
- Small Gastrointestinal Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,762 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 6 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 comparative matched-cohort study aims to evaluate the diagnostic performance of contrast-enhanced photon-counting computed tomography (PCCT) for detecting small gastrointestinal lesions compared with energy-integrating detector dual-energy computed tomography (DECT). The study includes a prospectively enrolled PCCT cohort and a retrospectively identified DECT cohort. Endoscopy with histopathology serves as the reference standard. Primary evaluation focuses on lesion detection, with additional assessment of lesion characterization, image quality, quantitative imaging parameters, and interobserver agreement.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCCT Diagnostic Cohort | – | Diagnostic Test: Contrast-Enhanced Photon-Counting Computed TomographyProspectively enrolled adults who underwent contrast-enhanced photon-counting computed tomography (PCCT) for evaluation of suspected small gastrointestinal lesions. Patients meeting the eligibility criteria were included in the diagnostic performance cohort and subsequently matched 1:1 with the retrospective DECT cohort using propensity score matching. |
| DECT Diagnostic Cohort | – | Diagnostic Test: Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed TomographyRetrospectively identified adults who underwent contrast-enhanced energy-integrating detector dual-energy computed tomography (DECT) for evaluation of suspected small gastrointestinal lesions. Eligible patients were matched 1:1 with the prospective PCCT cohort using propensity score matching for diagnostic performance comparison. |
| Prospective Clinical Implementation Cohort | – | Diagnostic Test: Contrast-Enhanced Photon-Counting Computed TomographyConsecutive adults undergoing routine contrast-enhanced abdominal photon-counting computed tomography (PCCT) in clinical practice. Patients with CT-positive findings suggestive of small gastrointestinal lesions were referred for endoscopy when appropriate to evaluate the clinical implementation of PCCT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes two cohorts: a retrospective diagnostic-performance cohort and a prospective clinical implementation cohort. Patients underwent contrast-enhanced photon-counting CT (PCCT) or energy-integrating detector dual-energy CT (DECT) for evaluation of suspected small gastrointestinal lesions in a clinical setting.
Key inclusion criteria (5 listed)
- Adults aged 18-80 years.
- Patients undergoing contrast-enhanced abdominal CT (photon-counting CT or energy-integrating detector dual-energy CT).
- At least one endoscopically detected or clinically suspected small gastrointestinal lesion.
- Lesions confirmed or suspected on endoscopy, pathology, or follow-up imaging.
- Lesions characterized as mucosal thickening or nodular lesions within predefined size criteria (≤2 cm).
Key exclusion criteria (5 listed)
- Prior gastrointestinal surgery affecting target evaluation region.
- Poor or nondiagnostic CT image quality.
- Incomplete or unavailable endoscopic or histopathological reference standard.
- Ambiguous lesion localization on endoscopy or imaging.
- Severe motion artifacts or inadequate bowel distension affecting diagnostic evaluation.
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 |
|---|---|---|
| Contrast-Enhanced Photon-Counting Computed TomographyAlso: PCCTContrast-enhanced abdominal photon-counting computed tomography performed for the detection and characterization of small gastrointestinal lesions. | Diagnostic test | PCCT Diagnostic Cohort, Prospective Clinical Implementation Cohort |
| Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed TomographyAlso: DECTContrast-enhanced abdominal energy-integrating detector dual-energy computed tomography performed for comparison of diagnostic performance in detecting and characterizing small gastrointestinal lesions. | Diagnostic test | DECT Diagnostic Cohort |
Primary outcome
Lesion-Based Detection Rate
Time frame: During the study period (January 2026 - March 2026)
Lesion-based detection rate of contrast-enhanced photon-counting CT compared with energy-integrating detector dual-energy CT using endoscopy with histopathology, when available, as the reference standard.
10 secondary outcomes
Positive Predictive Value of CT-Positive Findings
Time frame: During the study period (March 2026 to June 2026)
Yield of Clinically Actionable Lesions
Time frame: During the study period (March 2026 to June 2026)
Lesion-to-Mucosa Attenuation Difference
Time frame: During the study period (January 2026 - March 2026)
Image Noise
Time frame: During the study period (January 2026 - March 2026)
Signal-to-Noise Ratio
Time frame: During the study period (January 2026 - March 2026)
Contrast-to-Noise Ratio
Time frame: During the study period (January 2026 - March 2026)
Subjective Image Quality Score
Time frame: During the study period (January 2026 - March 2026)
Interobserver Agreement for Lesion Detection
Time frame: During the study period (January 2026 - June 2026)
Interobserver Agreement for Lesion Size Measurement
Time frame: During the study period (January 2026 - June 2026)
Interobserver Agreement for Diagnostic Confidence
Time frame: During the study period (January 2026 - March 2026)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. This study is an observational diagnostic accuracy study based on routinely collected clinical imaging and endoscopic data. Individual participant data will not be publicly shared due to patient privacy protection and institutional data governance restrictions. Only aggregated results will be reported in publications.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastrointestinal Lesions, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 10 Aug 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion-Based Detection Rate (time frame: During the study period (January 2026 - March 2026)). 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 10 Aug 2026.