Bladder CancerNCT03138837
Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage
An observational study of Bladder Cancer and Diagnoses Disease, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Diagnoses Disease, Magnetic Resonance Imaging
- What is being tested?
- Magnetic resonance imaging
- How many people
- 385 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2017to 15 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment of participants from single tertiary centre outpatient clinic of Urology and Nephrology Center in Mansoura
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Cardiac pacemaker
- Implanted cardioverter-defibrillator (ICD)
- Retained trans venous pacemaker and defibrillator leads
- Cochlear, otologic, or other ear implant
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516
Abdelwahab R. Hashem, Msc, 00201069678979, abdelwahab_hashem@yahoo.com
Mohammed H. Zahran, MD, 00201063338690, zahranmha@yahoo.com
About this study
Official title: Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage. Potential Role of the Apparent Diffusion Coefficient (ADC) Value
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
- Being tested
- Magnetic resonance imaging
- Keywords
- Bladder cancer, Magnetic Resonance Imaging, Bladder Cancer Superficial
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Diffusion Weighted Magnetic resonance imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer
comparing the radiological diagnosis with the pathological specimen results
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 May 2017 (estimated)
- Primary completion15 May 2018 (estimated)
- Study completion15 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Hassan Abol-Enein, MD, Study chair, Urology and Nephrology centerMohamed AboElghar, MD, Study director, Urology and Nephrology centerAhmed O. Mosbah, MD, Principal investigator, Urology and Nephrology centerKhaled Sheir, MD, Principal investigator, Urology and Nephrology centerAhmed Elassmy, MD, Principal investigator, Urology and Nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138837
- Sponsor's protocol ID
- R/17.02.31
- Status last verified
- May 2017
- First submitted
- 1 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage. Potential Role of the Apparent Diffusion Coefficient (ADC) Value
- ClinicalTrials.gov ID
- NCT03138837
- Acronym / sponsor ID
- R/17.02.31
- Conditions
- Bladder Cancer, Diagnoses Disease, Magnetic Resonance Imaging, Apparent Diffusion Coefficient
- Keywords
- Bladder cancer, Magnetic Resonance Imaging, Bladder Cancer Superficial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 May 2018 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of participants from single tertiary centre outpatient clinic of Urology and Nephrology Center in Mansoura
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Refuse to complete study requirements
- Patient with any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingDiffusion Weighted Magnetic resonance imaging | Diagnostic test | – |
Primary outcome
assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer
Time frame: 1 year
comparing the radiological diagnosis with the pathological specimen results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Diagnoses Disease, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelwahab R. Hashem, Msc (01069678979 ext. 002, abdelwahab_hashem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.