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

M

Mansoura University

Status

Unknown

Conditions

Bladder Cancer

Treatments

Device: mpMRI
Procedure: Second look TURBT

Study type

Interventional

Funder types

Other

Identifiers

NCT03914001
AE 2390

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

NMIBC patients
Other group
Description:
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
Treatment:
Procedure: Second look TURBT
Device: mpMRI

Trial contacts and locations

1

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Central trial contact

Amr A Elsawy, MD; Ahmed M Elshal

Data sourced from clinicaltrials.gov

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