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

NCT ID: NCT03914001

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NMIBC patients

eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks

Group Type OTHER

mpMRI

Intervention Type DEVICE

all eligible patients will undergo mpMRI 4 weks after initial TURBT

Second look TURBT

Intervention Type PROCEDURE

after mpMRI all patients will subjected to second look TURBT

Interventions

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mpMRI

all eligible patients will undergo mpMRI 4 weks after initial TURBT

Intervention Type DEVICE

Second look TURBT

after mpMRI all patients will subjected to second look TURBT

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amr Abdel-Lateif El-Sawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mosbah

Role: STUDY_CHAIR

Urology and Nephrology Center

Locations

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Urology and Nephrology Center

Al Mansurah, DK, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr A Elsawy, MD

Role: CONTACT

0502202222

Ahmed M Elshal

Role: CONTACT

+20502202222

Facility Contacts

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Amr A. Elsawy, MD

Role: primary

0020502202222

Other Identifiers

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AE 2390

Identifier Type: -

Identifier Source: org_study_id

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