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

NCT05324033 | Completed

• 1 other identifier: REC-FMHU 51/2021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Bladder

Keywords

cancer bladder; multiparametric MRI; VIRADS score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.

  6 month

Study Arms (2)

muscle invasive cancer bladder

Radiation: multiparametric MRI on the bladder; Procedure: diagnostic cystoscopy +/- TURBT

non-muscle invasive cancer bladder

Radiation: multiparametric MRI on the bladder; Procedure: diagnostic cystoscopy +/- TURBT

Interventions

multiparametric MRI on the bladder RADIATION

comparison between mpMRI and histopathology

muscle invasive cancer bladder; non-muscle invasive cancer bladder

diagnostic cystoscopy +/- TURBT PROCEDURE

conventional way of diagnosis

muscle invasive cancer bladder; non-muscle invasive cancer bladder

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people with suspected cancer bladder

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Faculty of medicine, Helwan university

Badr, Cairo Governorate, 11829, Egypt

Location

Related Publications (24)

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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of urosurgery

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

EG (1)