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OpenTrials
Completed

NCT Number: NCT05324033

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Helwan university

Badr, Cairo Governorate, 11829, Egypt

Who can participate

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

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).

Treatment and study plan

multiparametric MRI on the bladder

Radiation

comparison between mpMRI and histopathology

diagnostic cystoscopy +/- TURBT

Procedure

conventional way of diagnosis

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.

    Time frame: 6 month

Secondary outcomes

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

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Apr 4, 2023

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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