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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03138837
Other study ID # R/17.02.31
Secondary ID
Status Recruiting
Phase N/A
First received May 1, 2017
Last updated May 16, 2017
Start date May 15, 2017
Est. completion date May 15, 2018

Study information

Verified date May 2017
Source Mansoura University
Contact Abdelwahab R. Hashem, Msc
Phone 01069678979
Email abdelwahab_hashem@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 385
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Magnetic resonance imaging
Diffusion Weighted Magnetic resonance imaging

Locations

Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer comparing the radiological diagnosis with the pathological specimen results 1 year
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