MRI Contrast Media Adverse ReactionNCT04167631
Can VI-RADS/ADC Accurately Stage Bladder Cancer??
A study testing Multi-parametric MRI in people with MRI Contrast Media Adverse Reaction and Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease
- What is being tested?
- Multi-parametric MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour
Who cannot join
- fungating lesions
- beyond the scope of enbloc resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).
Read the detailed description
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).
We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS
- Conditions
- MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage
- Being tested
- Multi-parametric MRI
- Keywords
- VI-RADS, Multiparametric MRI, Non-muscle invasive bladder cancer (NMIBC), Muscle invasive bladder cancer (MIBC)
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Bladder Diseases, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-parametric MRIRadiation
Also called MP-MRI
Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
| Study group | Role | What they receive |
|---|---|---|
| Multiparametric MRI | Other | Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI. Receives: Radiation: Multi-parametric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Dec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI Contrast Media Adverse ReactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Laymon, Mansoura University
- Investigators
- Ahmed Mosbah, MD, Study chair, Mansoura UniversityMohammed Aboelghar, MD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167631
- Sponsor's protocol ID
- MANS.VI-RADS
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2019
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04167631
- Acronym / sponsor ID
- MANS.VI-RADS
- Conditions
- MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage
- Keywords
- VI-RADS, Multiparametric MRI, Non-muscle invasive bladder cancer (NMIBC), Muscle invasive bladder cancer (MIBC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Nov 2019 (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.
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).
Detailed description
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).
We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiparametric MRI | Other | Radiation: Multi-parametric MRIVesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour
Key exclusion criteria (2 listed)
- fungating lesions
- beyond the scope of enbloc resection
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 |
|---|---|---|
| Multi-parametric MRIAlso: MP-MRIVesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI. | Radiation | Multiparametric MRI |
Primary outcome
Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
Time frame: 18 months
assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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.
Ahmed Mosbah, MD study chair
Mansoura University
Mohammed Aboelghar, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-parametric MRI in people with MRI Contrast Media Adverse Reaction and Bladder Cancer, 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 1 inclusion and 2 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 30 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI. (time frame: 18 months). 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 30 Oct 2024.