MultiparametricNCT07578233
Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Muscle Invasive Bladder Cancer
An observational study of Multiparametric and Magnetic Resonance Imaging, run by Ain Shams University at 1 site in Egypt.
Trial summary
This research aimed to determine how accurately multiparametric magnetic resonance imaging (MRI), when interpreted using the VI-RADS scoring system, can distinguish between invasive and non-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiparametric, Magnetic Resonance Imaging, Validation
- What is being tested?
- Magnetic resonance imaging
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Mar 2025
- 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: This cross-sectional study involved 60 patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy. The study was carried out with approval from the Ethical Committee at our institute. Informed written consent was obtained from all participants.
Who may be able to join
- Both sexes.
- Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy.
Who cannot join
- Contraindications to MRI (such as metallic prostheses or pacemakers).
- Contraindications to Transurethral Resection (like unfitness for anesthesia or urethral strictures).
- Elevated serum creatinine levels (precluding IV contrast-enhanced imaging).
Trial locations and contacts
1 site in 1 country.
About this study
This research aimed to determine how accurately multiparametric magnetic resonance imaging (MRI), when interpreted using the VI-RADS scoring system, can distinguish between invasive and non-invasive bladder cancer.
Read the detailed description
Bladder cancer (BC) is among the most widespread malignancies needing management. The majority of bladder cancers are urothelial cell carcinomas, which are further classified histologically into low-grade and high-grade categories.
Multiparametric magnetic resonance imaging (mpMRI), a recent advancement in MRI technology, combines functional sequences like DWI and DCE-MRI with anatomical T1- and T2-weighted images. This integrated approach enhances tumor detection and staging accuracy, aids in post-therapy response monitoring, and facilitates the identification of local disease recurrence.
- Conditions
- Multiparametric, Magnetic Resonance Imaging, Validation, Vesical Imaging Reporting and Data System (VI-RADS), Muscle Invasive Bladder Cancer
- Being tested
- Magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
All patients underwent magnetic resonance imaging evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging, who were scheduled for cystoscopy Receives: Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of VI-RADS score for invasion through the bladder wall
Sensitivity of VI-RADS score for invasion through the bladder wall was recorded.
At the end VI-RADS scoring was calculated using all categories, to know the probability of muscle invasion as follows: VI-RADS 1 (very low probability of muscle invasion ): SC, CE, and DW category 1; VI-RADS 2 (low probability of muscle invasion): SC, CE, and DW category 2; both CE and DW category 2 with SC category 3; VI-RADS 3 (muscle invasion is equivocal): SC, CE, and DW category 3; SC category 3 and CE or DW category 3, with the remaining sequence in category 2; (Category 3 should be applied when category 2 findings are absent in their respective sequences but there is no apparent disruption of the typical SI in the muscularis propria, there may be Misclassifications in the VI-RADS 2-3 group).
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultiparametricStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578233
- Sponsor's protocol ID
- FMASU MS 293a/2021/2024
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07578233
- Acronym / sponsor ID
- FMASU MS 293a/2021/2024
- Conditions
- Multiparametric, Magnetic Resonance Imaging, Validation, Vesical Imaging Reporting and Data System (VI-RADS), Muscle Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 11 May 2026 (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.
This research aimed to determine how accurately multiparametric magnetic resonance imaging (MRI), when interpreted using the VI-RADS scoring system, can distinguish between invasive and non-invasive bladder cancer.
Detailed description
Bladder cancer (BC) is among the most widespread malignancies needing management. The majority of bladder cancers are urothelial cell carcinomas, which are further classified histologically into low-grade and high-grade categories.
Multiparametric magnetic resonance imaging (mpMRI), a recent advancement in MRI technology, combines functional sequences like DWI and DCE-MRI with anatomical T1- and T2-weighted images. This integrated approach enhances tumor detection and staging accuracy, aids in post-therapy response monitoring, and facilitates the identification of local disease recurrence.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Magnetic resonance imagingPatients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging, who were scheduled for cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study involved 60 patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy. The study was carried out with approval from the Ethical Committee at our institute. Informed written consent was obtained from all participants.
Key inclusion criteria (2 listed)
- Both sexes.
- Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy.
Key exclusion criteria (3 listed)
- Contraindications to MRI (such as metallic prostheses or pacemakers).
- Contraindications to Transurethral Resection (like unfitness for anesthesia or urethral strictures).
- Elevated serum creatinine levels (precluding IV contrast-enhanced imaging).
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 imagingAll patients underwent magnetic resonance imaging evaluation. | Other | Study group |
Primary outcome
Sensitivity of VI-RADS score for invasion through the bladder wall
Time frame: 3 months after the procedure
Sensitivity of VI-RADS score for invasion through the bladder wall was recorded. At the end VI-RADS scoring was calculated using all categories, to know the probability of muscle invasion as follows: VI-RADS 1 (very low probability of muscle invasion ): SC, CE, and DW category 1; VI-RADS 2 (low probability of muscle invasion): SC, CE, and DW category 2; both CE and DW category 2 with SC category 3; VI-RADS 3 (muscle invasion is equivocal): SC, CE, and DW category 3; SC category 3 and CE or DW category 3, with the remaining sequence in category 2; (Category 3 should be applied when category 2 findings are absent in their respective sequences but there is no apparent disruption of the typical SI in the muscularis propria, there may be Misclassifications in the VI-RADS 2-3 group).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multiparametric and Magnetic Resonance Imaging, run by Ain Shams 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of VI-RADS score for invasion through the bladder wall (time frame: 3 months after the procedure). 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 11 May 2026.