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

Cancer, Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324033
• Other study ID #: REC-FMHU 51/2021
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer, Bladder
• Urinary Bladder Neoplasms

Intervention

Radiation:
• multiparametric MRI on the bladder
comparison between mpMRI and histopathology

Procedure:
• diagnostic cystoscopy +/- TURBT
conventional way of diagnosis

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Helwan university	Badr	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.		6 month