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

NCT ID: NCT03138837

Last Updated: 2017-05-17

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

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer Diagnoses Disease Magnetic Resonance Imaging Apparent Diffusion Coefficient

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetic resonance imaging

Diffusion Weighted Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
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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Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hassan Abol-Enein, MD

Role: STUDY_CHAIR

Urology and Nephrology center

Mohamed AboElghar, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Ahmed O. Mosbah, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Khaled Sheir, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Ahmed Elassmy, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdelwahab R. Hashem, Msc

Role: CONTACT

01069678979 ext. 002

Mohammed H. Zahran, MD

Role: CONTACT

01063338690 ext. 002

Facility Contacts

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Abdelwahab R. Hashem, Msc

Role: primary

00201069678979

Mohammed H. Zahran, MD

Role: backup

00201063338690

Other Identifiers

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R/17.02.31

Identifier Type: -

Identifier Source: org_study_id

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