Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 6, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedApril 12, 2019
April 1, 2019
1 year
April 6, 2019
April 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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.
1 year
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).
1 year
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
1 year
- +3 more secondary outcomes
Study Arms (1)
NMIBC patients
OTHEReligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
Interventions
after mpMRI all patients will subjected to second look TURBT
Eligibility Criteria
You may qualify if:
- Ability to give informed consent.
- Patients with primary or recurrent papillary NMIBC.
- Normal cardiac, hematological, and renal functions.
You may not qualify if:
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Al Mansurah, DK, 35516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Mosbah
Urology and Nephrology Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2019
First Posted
April 12, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2020
Study Completion
June 1, 2020
Last Updated
April 12, 2019
Record last verified: 2019-04