CT KUB in Renal Cysts
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients referred for CT KUB with detectable Renal cysts
Disqualifiers
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 population
Patients with Renal Cysts referred to CT KUB for any indication
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
CT scan
DeviceAll Patients will undergo CT KUB cyst evaluation Qualitatively regarding Gross Picture in Imaging and Quantitavely using Hausfield units then patients will undergo Abdomianl ultrasound
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: