Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study

Bladder Cancer Clinical Trial

Official title:

Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914001
• Other study ID #: AE 2390
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2019
• Source: Mansoura University
• Contact: Amr A Elsawy, MD
• Phone: 0502202222
• Email: amrelsawy.unc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.

Description:

Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination.

The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to give informed consent.

2. Patients with primary or recurrent papillary NMIBC.

3. Normal cardiac, hematological, and renal functions.

Exclusion Criteria:

• 1. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• mpMRI
all eligible patients will undergo mpMRI 4 weks after initial TURBT

Procedure:
• Second look TURBT
after mpMRI all patients will subjected to second look TURBT

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT	assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test).	1 year
Secondary	Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.	Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.	1 year
Secondary	2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.	2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.	1 year
Secondary	Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.	Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.	1 year
Secondary	Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).	Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).	1 year
Secondary	Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.	Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.	1 year
Secondary	Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.	Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.	1 year
Secondary	Readmission rate after second look TURBT.	Readmission rate after second look TURBT.	1 year
Secondary	Cost comparison of mpMRI and second look TURBT.	Cost comparison of mpMRI and second look TURBT.	1 year