CT KUB in Renal Cysts

NCT07187791 | Not Yet Recruiting

• 1 other identifier: CT in Renal cysts
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Primary (main):
2. 2.Secondary (subsidiary):
3. 3.Assess interobserver agreement in CT KUB interpretation among radiologists with varying levels of expertise.
4. 4.Identify limitations and pitfalls in the use of non-contrast CT KUB for characterizing renal cysts.

Conditions

CT KUB; Renal Cyst

Outcome Measures

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.

  From Time of CT KUB referal till accurate diagnosis of Cystic lesion up to 24 weeks

Interventions

CT scan DEVICE

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

Also known as: Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Renal Cysts referred to CT KUB for any indication

You may qualify if:

• Patients referred for CT KUB with detectable Renal cysts

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 22106359 BACKGROUND

MeSH Terms

Interventions

Tomography, X-Ray Computed; Ultrasonography

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Thomas Nabeel Saied, Resident Doctor

CONTACT

+201012056837; tomaas.17289622@med.aun.edu.eg

Hisham Mostafa Imam, Professor

CONTACT

+201223971369; hishimimam@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09