Urothelial Bladder CancerNCT06335667
mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
A study testing mpMRI + Diagnostic TURBT in people with Urothelial Bladder Cancer and Muscle-Invasive Bladder Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Bladder Cancer, Muscle-Invasive Bladder Cancer
- What is being tested?
- mpMRI + Diagnostic TURBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years old or greater at the time of consent.
- Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.
- ECOG Performance Status of 0-3.
- Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
- Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.
Who cannot join
- Prior TURBT within 120 days of study entry.
- Prior therapy for bladder cancer within 180 days of study entry.
- Inability to tolerate mpMRI or associated contrast.
- Inability to tolerate TURBT or associated anesthesia.
- ECOG Performance Status of 4.
- Female patient who is known to be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Nataliya Mar, MD, 1-877-827-8839, ucstudy@uci.edu
About this study
Official title: Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study
This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).
- Being tested
- mpMRI + Diagnostic TURBT
- Keywords
- mpMRI, TURBT, VI-RADS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRI + Diagnostic TURBTDiagnostic test
mpMRI in addition to the TURBT surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| mpMRI + Diagnostic TURBT | Experimental | Not described Receives: Diagnostic Test: mpMRI + Diagnostic TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.
VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.
Measured: Up to 1 year
Secondary outcomes (7)
Progression free survival (PFS) with mpMRI compared to diagnostic TURBT
Time from diagnostic test to cancer progression, recurrence, or death.
Measured: up to 5 years
Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy
Measured: up to 5 years
Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).
Measured: up to 5 years
Incidence of adverse events with mpMRI versus diagnostic TURBT.
Measured: up to 5 years
Patient Quality of Life with mpMRI versus diagnostic TURBT.
As assessed by quality of life questionnaires
Measured: up to 5 years
Incidence of repeat TURBT.
Measured: up to 5 years
Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT
in dollars
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start27 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nataliya Mar, University of California, Irvine
- Investigators
- Nataliya Mar, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335667
- Sponsor's protocol ID
- 4565
- Other IDs
- UCI 23-72
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study
- ClinicalTrials.gov ID
- NCT06335667
- Acronym / sponsor ID
- 4565
- Keywords
- mpMRI, TURBT, VI-RADS score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 28 Mar 2024 (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 is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mpMRI + Diagnostic TURBT | Experimental | Diagnostic Test: mpMRI + Diagnostic TURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years old or greater at the time of consent.
- Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.
- ECOG Performance Status of 0-3.
- Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
- Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.
Key exclusion criteria (6 listed)
- Prior TURBT within 120 days of study entry.
- Prior therapy for bladder cancer within 180 days of study entry.
- Inability to tolerate mpMRI or associated contrast.
- Inability to tolerate TURBT or associated anesthesia.
- ECOG Performance Status of 4.
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 |
|---|---|---|
| mpMRI + Diagnostic TURBTmpMRI in addition to the TURBT surgical procedure | Diagnostic test | mpMRI + Diagnostic TURBT |
Primary outcome
Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.
Time frame: Up to 1 year
VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.
7 secondary outcomes
Progression free survival (PFS) with mpMRI compared to diagnostic TURBT
Time frame: up to 5 years
Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy
Time frame: up to 5 years
Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).
Time frame: up to 5 years
Incidence of adverse events with mpMRI versus diagnostic TURBT.
Time frame: up to 5 years
Patient Quality of Life with mpMRI versus diagnostic TURBT.
Time frame: up to 5 years
Incidence of repeat TURBT.
Time frame: up to 5 years
Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Nataliya Mar, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMRI + Diagnostic TURBT in people with Urothelial Bladder Cancer and Muscle-Invasive Bladder Cancer, run by University of California, Irvine at 1 site in United States.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT. (time frame: Up to 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 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.