CT KUBNCT07187791
CT KUB in Renal Cysts
An observational study of CT KUB and Renal Cyst, run by Assiut University.
Trial summary
1. Primary (main): 1. Determine the diagnostic accuracy of CT KUB in differentiating between benign and suspicious renal cysts according to the Bosniak classification. 2. Secondary (subsidiary): 1. Assess interobserver agreement in CT KUB interpretation among radiologists with varying levels of expertise. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CT KUB, Renal Cyst
- What is being tested?
- CT scan
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Oct 2027
- How long will I take part?
- 6 Months
- 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: Patients with Renal Cysts referred to CT KUB for any indication
Who may be able to join
- Patients referred for CT KUB with detectable Renal cysts
Who cannot join
- 1-Patients with known renal tumors.
- 2-Inadequate imaging quality: CT KUB with severe motion/streak artifact or incomplete anatomical coverage preventing lesion assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of CT KUB in Assesment of Renal Cysts
- Primary (main):
- Determine the diagnostic accuracy of CT KUB in differentiating between benign and suspicious renal cysts according to the Bosniak classification.
- Secondary (subsidiary):
- Assess interobserver agreement in CT KUB interpretation among radiologists with varying levels of expertise.
- Identify limitations and pitfalls in the use of non-contrast CT KUB for characterizing renal cysts.
Read the detailed description
Renal cysts are among the most frequently encountered incidental findings(1) on abdominal imaging, particularly with the increasing use of cross-sectional imaging. Most simple cysts are benign and require no further evaluation.
However, complex cystic lesions pose a diagnostic challenge, necessitating accurate characterization to distinguish benign from malignant lesions.(2).
While CT KUB is highly effective for detecting urinary tract stones, there are several limitations and pitfalls we should be aware of as Limited Soft Tissue Assessment as without contrast, masses, infections, or vascular lesions may not be clearly visible also some tumors called isodensity tumors, have similar intensity values to the surrounding normal tissues.(3).
Segmentation of kidney tumors on CT KUB images adds challenges compared to contrast-enhanced CT (CECT) images, due to low contrast and lack of multiphase images. On CECT images, the kidney tumors have different intensity values compared to the normal tissues.(4).
Validating CT KUB's accuracy in assessing renal cysts could have significant implications for clinical decision making, especially in resource-limited or urgent care settings
- Conditions
- CT KUB, Renal Cyst
- Being tested
- CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDevice
Also called Ultrasound
All Patients will undergo CT KUB cyst evaluation Qualitatively regarding Gross Picture in Imaging and Quantitavely using Hausfield units then patients will undergo Abdomianl ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Validiation of CT KUB results in assesment of Renal Cystic Lesions prospectively in comparison to Ultrasonographic as in terms of Sensitivity and Specificity regarding evalution of Cystic lesion complexity according to Bosniak Classification
CT KUB cyst evaluation Qualitatively as Gross Picture and Quantitavely using Hausfield units then Abdomianl ultrasound , otherwise Bosniak I Renal cysts will undergo further assessment contrast-enhanced CT then Follow Up or Histopathology Data will be captured on a pre-piloted electronic case report form with de-identified study codes. Statistical analysis (sensitivity, specificity, PPV, NPV, accuracy, ROC/AUC) and inter-/intra-observer agreement (κ/ICC) will be conducted using SPSS/R/Stata. Quality assurance will follow institutional scanner QA logs, a priori reader calibration, and an audit-trailed database.
Measured: From Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CT KUBStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nabeel Mikha Saied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187791
- Sponsor's protocol ID
- CT in Renal cysts
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Forookhi, A., Bicchetti, M., Lucciola, S. et al. The thin line that made the difference: a case report on a Bosniak IIF renal cystic mass treated with cyst decortication. Egypt J Radiol Nucl Med 53, 115 (2022). https://doi.org/10.1186/s43055-022-00791-3
Smith AD, Remer EM, Cox KL, Lieber ML, Allen BC, Shah SN, Herts BR. Bosniak category IIF and III cystic renal lesions: outcomes and associations. Radiology. 2012 Jan;262(1):152-60. doi: 10.1148/radiol.11110888. Epub 2011 Nov 21.
PubMed 22106359
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of CT KUB in Assesment of Renal Cysts
- ClinicalTrials.gov ID
- NCT07187791
- Acronym / sponsor ID
- CT in Renal cysts
- Conditions
- CT KUB, Renal Cyst
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 23 Sep 2025 (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.
- Primary (main):
- Determine the diagnostic accuracy of CT KUB in differentiating between benign and suspicious renal cysts according to the Bosniak classification.
- Secondary (subsidiary):
- Assess interobserver agreement in CT KUB interpretation among radiologists with varying levels of expertise.
- Identify limitations and pitfalls in the use of non-contrast CT KUB for characterizing renal cysts.
Detailed description
Renal cysts are among the most frequently encountered incidental findings(1) on abdominal imaging, particularly with the increasing use of cross-sectional imaging. Most simple cysts are benign and require no further evaluation.
However, complex cystic lesions pose a diagnostic challenge, necessitating accurate characterization to distinguish benign from malignant lesions.(2).
While CT KUB is highly effective for detecting urinary tract stones, there are several limitations and pitfalls we should be aware of as Limited Soft Tissue Assessment as without contrast, masses, infections, or vascular lesions may not be clearly visible also some tumors called isodensity tumors, have similar intensity values to the surrounding normal tissues.(3).
Segmentation of kidney tumors on CT KUB images adds challenges compared to contrast-enhanced CT (CECT) images, due to low contrast and lack of multiphase images. On CECT images, the kidney tumors have different intensity values compared to the normal tissues.(4).
Validating CT KUB's accuracy in assessing renal cysts could have significant implications for clinical decision making, especially in resource-limited or urgent care settings
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Renal Cysts referred to CT KUB for any indication
Key inclusion criteria (1 listed)
- Patients referred for CT KUB with detectable Renal cysts
Key exclusion criteria (2 listed)
- 1-Patients with known renal tumors.
- 2-Inadequate imaging quality: CT KUB with severe motion/streak artifact or incomplete anatomical coverage preventing lesion assessment.
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 |
|---|---|---|
| CT scanAlso: UltrasoundAll Patients will undergo CT KUB cyst evaluation Qualitatively regarding Gross Picture in Imaging and Quantitavely using Hausfield units then patients will undergo Abdomianl ultrasound | Device | – |
Primary outcome
Validiation of CT KUB results in assesment of Renal Cystic Lesions prospectively in comparison to Ultrasonographic as in terms of Sensitivity and Specificity regarding evalution of Cystic lesion complexity according to Bosniak Classification
Time frame: From Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeks
CT KUB cyst evaluation Qualitatively as Gross Picture and Quantitavely using Hausfield units then Abdomianl ultrasound , otherwise Bosniak I Renal cysts will undergo further assessment contrast-enhanced CT then Follow Up or Histopathology Data will be captured on a pre-piloted electronic case report form with de-identified study codes. Statistical analysis (sensitivity, specificity, PPV, NPV, accuracy, ROC/AUC) and inter-/intra-observer agreement (κ/ICC) will be conducted using SPSS/R/Stata. Quality assurance will follow institutional scanner QA logs, a priori reader calibration, and an audit-trailed database.
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 23 Sep 2025.
- BackgroundForookhi, A., Bicchetti, M., Lucciola, S. et al. The thin line that made the difference: a case report on a Bosniak IIF renal cystic mass treated with cyst decortication. Egypt J Radiol Nucl Med 53, 115 (2022). https://doi.org/10.1186/s43055-022-00791-3
- Background: PubMed 22106359Smith AD, Remer EM, Cox KL, Lieber ML, Allen BC, Shah SN, Herts BR. Bosniak category IIF and III cystic renal lesions: outcomes and associations. Radiology. 2012 Jan;262(1):152-60. doi: 10.1148/radiol.11110888. Epub 2011 Nov 21.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of CT KUB and Renal Cyst, run by Assiut University.
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 1 inclusion and 2 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Thomas Nabeel Saied, Resident Doctor (+201012056837, tomaas.17289622@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validiation of CT KUB results in assesment of Renal Cystic Lesions prospectively in comparison to Ultrasonographic as in terms of Sensitivity and Specificity regarding evalution of Cystic lesion complexity according to Bosniak Classification (time frame: From Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07187791, which also lists 2 linked publications.
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 23 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.