Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer

Completed

• Conditions: Cancer, Bladder
• Interventions: Radiation: multiparametric MRI on the bladder; Procedure: diagnostic cystoscopy +/- TURBT

• Registration Number: NCT05324033
• Lead Sponsor: Helwan University

Brief Summary

Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans.Therefore, this study will try to evaluate the sensitivity and reliability of mpMRI in accurate diagnosis of cancer bladder.

Primary objective: to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Study Start: 2022-05-01
• Primary Completion: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Study Completion: 2023-04-01
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients diagnosed with NMIBC or MIBC during diagnostic cystoscopy or by any radiologic investigation in the Urology department of Helwan university hospitals without being restricted to age or sex.
• All histological types of bladder cancer
• Newly diagnosed, recurrent cases, or even patients undergoing follow-up cystoscopy.

Exclusion Criteria

• Patients with elevated renal function according to their age as this will be a contraindication to DCE MRI.
• Patients with absolute contraindication to MRI (e.g.: metallic prosthesis).
• Patients with contraindication to undergo TURBT (e.g.: unfit for surgery).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
muscle invasive cancer bladder	diagnostic cystoscopy +/- TURBT	-
non-muscle invasive cancer bladder	multiparametric MRI on the bladder	-
non-muscle invasive cancer bladder	diagnostic cystoscopy +/- TURBT	-
muscle invasive cancer bladder	multiparametric MRI on the bladder	-

Primary Outcome Measures

Name	Time	Method
to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.	6 month

Secondary Outcome Measures

Name	Time	Method
the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.	6 month

Trial Locations

Locations (1)

Faculty of medicine, Helwan university; 🇪🇬 Badr, Cairo, Egypt