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NCT Number: NCT07187791

CT KUB in Renal Cysts

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Ultrasound

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hisham Mostafa Imam, Professor

CONTACT

[email protected]

+201223971369

Thomas Nabeel Saied, Resident Doctor

CONTACT

[email protected]

+201012056837

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Validation of CT KUB in Assesment of Renal Cysts

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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