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CT KUB in Renal Cysts

Validation of CT KUB in Assesment of Renal Cysts

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07187791
Enrollment
200
Registered
2025-09-23
Start date
2025-10-01
Completion date
2027-10-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CT KUB, Renal Cyst

Brief 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. 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

Interventions

DEVICECT scan

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients referred for CT KUB with detectable Renal cysts

Exclusion criteria

* 1-Patients with known renal tumors. * 2-Inadequate imaging quality: CT KUB with severe motion/streak artifact or incomplete anatomical coverage preventing lesion assessment.

Design outcomes

Primary

MeasureTime frameDescription
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 ClassificationFrom Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeksCT 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.

Contacts

Primary ContactThomas Nabeel Saied, Resident Doctor
tomaas.17289622@med.aun.edu.eg+201012056837
Backup ContactHisham Mostafa Imam, Professor
hishimimam@aun.edu.eg+201223971369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026