Clinical trial NCT05324033: Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer
Official title: Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Bladder
Keywords: cancer bladder
multiparametric MRI
VIRADS score
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with suspected cancer bladder

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 6 month
Secondary outcomes:
measure: the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.
timeFrame: 6 month
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Faculty of medicine, Helwan university
state: Cairo
Study officials:
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