Role of Diffusion -Weighted MRI in Evaluation of Urinary Bladder Masses

October 17, 2021 updated by: Walaa Refaat Abdellah, Sohag University

Urinary bladder cancer is a common malignant tumor of the urinary tract in both men and women. Proper management of the urinary bladder cancer depends on the stage of the lesions.

Differentiating the histopathological types, tumor grade and the depth of tumor invasion are very important for determining the therapeutic approach and are highly correlated with the recurrence, progression and patient's survival.

Radical cystectomy (RC) and lymphadenectomy after neoadjuvant chemotherapy is the standard treatment for muscle invasive tumors, whereas the treatment of choice for non-muscle invasive tumors is transurethral resection (TUR) ±chemo/immunotherapy.

Cystoscopy with biopsy is still the best tool for bladder cancer staging due to its high sensitivity in detecting lesions and the possibilities of tumor resections, but the main drawbacks are invasiveness, limitation in detection of flat lesions, and lack of the assessment of extra-vesical tumor invasion. Modern diagnostic modalities circumvent these limitations like blue-light cystoscopic examination and infrared cystoscopy.

For the radiological evaluation of the urinary bladder, magnetic resonance imaging (MRI) is a valuable imaging modality due to high tissue contrast and multiplanar imaging capabilities.

Diffusion-weighted images provides useful information for evaluation of local T stage of the urinary bladder cancer, specially in differentiating T1 stage or lower tumors from T2 stage and higher tumor stages.

Apparent diffusion coefficient (ADC) delineating the degree of water molecular diffusion and the degree of restriction to water diffusion in biological tissues is inversely correlated to the integrity of the cell membranes and the tissue cellularity.

The apparent diffusion coefficient (ADC) value has been revealed as quantitative measure of the degree of malignancy of the lesions. Decreased ADC values were reported with malignant lesions which have a larger cell diameter and more cellularity than normal tissue.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammed TH Mahmoud, professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient presenting with heamaturia or intractable cystitis and urinary bladder mass lesions detected on ultrasound and/or CT examinations (with contrast).

Description

Inclusion Criteria :• Age, any age will be included

  • Sex, both genders are included.
  • Patient presenting with heamaturia or intractable cystitis and urinary bladder mass lesions detected on ultrasound and/or CT examinations (with contrast).

Exclusion Criteria:

• General contraindications to MR imaging (pacemaker, metallic prostheses and clostrophobia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
urilogic patients
Device: MRI
MRI sequences: TI. T2 and diffusion weighted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of urinary bladder masses
Time Frame: 2 years
detection and grading of urinary bladder masses using ADC value and pattern of signal of restriction in diffusion weighted image .
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

October 17, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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