Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage

May 16, 2017 updated by: Abdelwahab Hashem, Mansoura University

Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage. Potential Role of the Apparent Diffusion Coefficient (ADC) Value

assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and potential role of the ADC value as a biomarker reflecting histological grade and stage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

385

Contacts and Locations

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

Study Locations

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Recruitment of participants from single tertiary centre outpatient clinic of Urology and Nephrology Center in Mansoura

Description

Inclusion Criteria:

  • Men and women 18 years or older
  • Suspected by the out-patient flexible cystoscopy as Non-muscle invasive bladder cancer.
  • Patient who will undergo radical cystectomy.
  • Patient with history of allergy to iodinated contrast media

Exclusion Criteria:

  • Refuse to complete study requirements

  • Patient with any of the following:

    1. Any metallic fragment or foreign body
    2. Coronary and peripheral artery stents
    3. Aortic stent graft
    4. Prosthetic heart valves and annuloplasty rings
    5. Cardiac pacemaker
    6. Implanted cardioverter-defibrillator (ICD)
    7. Retained trans venous pacemaker and defibrillator leads
    8. Cochlear, otologic, or other ear implant

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer
Time Frame: 1 year
comparing the radiological diagnosis with the pathological specimen results
1 year

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Chair: Hassan Abol-Enein, MD, Urology and nephrology center
  • Study Director: Mohamed AboElghar, MD, Urology and nephrology center
  • Principal Investigator: Ahmed O. Mosbah, MD, Urology and nephrology center
  • Principal Investigator: Khaled Sheir, MD, Urology and nephrology center
  • Principal Investigator: Ahmed Elassmy, MD, Urology and nephrology center

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)

May 15, 2017

Primary Completion (Anticipated)

May 15, 2018

Study Completion (Anticipated)

May 15, 2018

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/17.02.31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

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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