Role of 3 Tesla Diffusion Weighted Magnetic Resonance Ima... | NCT03138837

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2017Estimated

Primary Completion Date

May 15, 2018Estimated

Completion Date

May 15, 2018Estimated

First Submitted Date

May 1, 2017

First Submission Date that Met QC Criteria

May 1, 2017

First Posted Date

May 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2017

Last Update Posted Date

May 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

385Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic resonance imaging	Diagnostic Test	Diffusion Weighted Magnetic resonance imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelwahab R. Hashem, Msc	Contact	01069678979	002	abdelwahab_hashem@yahoo.com
Mohammed H. Zahran, MD	Contact	01063338690	002	zahranmha@yahoo.com

Overall Officials

Name	Affiliation	Role
Hassan Abol-Enein, MD	Urology and Nephrology center	Study Chair
Mohamed AboElghar, MD	Urology and Nephrology center	Study Director
Ahmed O. Mosbah, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center	Recruiting	Al Mansurah	Aldakahlia	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis