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

NCT03138837 | Unknown DMC

• 1 other identifier: R/17.02.31
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Diagnoses Disease; Magnetic Resonance Imaging; Apparent Diffusion Coefficient

Keywords

Bladder cancer; Magnetic Resonance Imaging; Bladder Cancer Superficial

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

Diffusion Weighted Magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Refuse to complete study requirements
• Patient with any of the following:
• Any metallic fragment or foreign body
• Coronary and peripheral artery stents
• Aortic stent graft
• Prosthetic heart valves and annuloplasty rings
• Cardiac pacemaker
• Implanted cardioverter-defibrillator (ICD)
• Retained trans venous pacemaker and defibrillator leads
• Cochlear, otologic, or other ear implant

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder Biopsy

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hassan Abol-Enein, MD

  Urology and Nephrology center

  STUDY CHAIR

• Mohamed AboElghar, MD

  Urology and Nephrology center

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab R. Hashem, Msc

CONTACT

01069678979; abdelwahab_hashem@yahoo.com

Mohammed H. Zahran, MD

CONTACT

01063338690; zahranmha@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)