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Status unknownNCT03138837Updated May 17, 2017

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

An observational study in Bladder Cancer, Diagnoses Disease and Magnetic Resonance Imaging, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Mansoura University · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
385
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Bladder cancer
  • Magnetic Resonance Imaging
  • Bladder Cancer Superficial
03

In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's planned enrollment of 385 is above the median of 179 across 385 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Mansoura University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
385 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testMagnetic resonance imaging

    Diffusion Weighted Magnetic resonance imaging

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Urology and Nephrology Center
    Al Mansurah, Aldakahlia 35516, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03138837
Lead sponsor
Mansoura University
Responsible party
Abdelwahab Hashem (Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura University) — Principal investigator
First posted
May 3, 2017
Start date
May 15, 2017 (estimated)
Primary completion
May 15, 2018 (estimated)
Completion
May 15, 2018 (estimated)
Last update
May 17, 2017

Study contacts

Abdelwahab R. Hashem, Msc
Contact
abdelwahab_hashem@yahoo.com
01069678979 ext. 002
Mohammed H. Zahran, MD
Contact
zahranmha@yahoo.com
01063338690 ext. 002
Hassan Abol-Enein, MD
study chair · Urology and Nephrology center
Mohamed AboElghar, MD
study director · Urology and Nephrology center
Ahmed O. Mosbah, MD
principal investigator · Urology and Nephrology center
Khaled Sheir, MD
principal investigator · Urology and Nephrology center
Ahmed Elassmy, MD
principal investigator · Urology and Nephrology center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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