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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138837
Recruitment Status : Unknown
Verified May 2017 by Abdelwahab Hashem, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 3, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

Brief Summary:
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.

Condition or disease Intervention/treatment
Bladder Cancer Diagnoses Disease Magnetic Resonance Imaging Apparent Diffusion Coefficient Diagnostic Test: Magnetic resonance imaging

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Study Type : Observational
Estimated Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Magnetic resonance imaging
    Diffusion Weighted Magnetic resonance imaging


Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Bladder Biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recruitment of participants from single tertiary centre outpatient clinic of Urology and Nephrology Center in Mansoura
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138837


Contacts
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Contact: Abdelwahab R. Hashem, Msc 01069678979 ext 002 abdelwahab_hashem@yahoo.com
Contact: Mohammed H. Zahran, MD 01063338690 ext 002 zahranmha@yahoo.com

Locations
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Egypt
Urology and Nephrology Center Recruiting
Mansoura, Aldakahlia, Egypt, 35516
Contact: Abdelwahab R. Hashem, Msc    00201069678979    abdelwahab_hashem@yahoo.com   
Contact: Mohammed H. Zahran, MD    00201063338690    zahranmha@yahoo.com   
Sponsors and Collaborators
Mansoura University
Investigators
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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
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Responsible Party: Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03138837    
Other Study ID Numbers: R/17.02.31
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdelwahab Hashem, Mansoura University:
Bladder cancer
Magnetic Resonance Imaging
Bladder Cancer Superficial
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases