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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: mpMRI; Procedure: Second look TURBT

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 35516
      • Recruiting
      • Urology and nephrology center
      • Contact: Amr A. Elsawy, MD; Phone Number: 0020502202222; Email: amrelsawy.unc@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NMIBC patients; eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Readmission rate after second look TURBT.	Readmission rate after second look TURBT.	1 year
Cost comparison of mpMRI and second look TURBT.	Cost comparison of mpMRI and second look TURBT.	1 year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed Mosbah, Urology and nephrology center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: multiparametric magnetic resonance imaging; Non muscle invasive bladder cancer; second resection
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: AE 2390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No