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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06335667
Other study ID # 4565
Secondary ID UCI 23-72
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2024
Est. completion date April 2030

Study information

Verified date May 2024
Source University of California, Irvine
Contact Chao Family Comprehensive Cancer Center University of California
Phone 1-877-827-8839
Email ucstudy@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 2030
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 urologist 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. Exclusion Criteria: - Prior TURBT within 120 days of study entry. - Prior therapy for bladder cancer within 120 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.

Study Design


Intervention

Diagnostic Test:
mpMRI + Diagnostic TURBT
mpMRI in addition to the TURBT surgical procedure

Locations

Country Name City State
United States Chao Family Comprehensive Cancer Center University of California, Irvine Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 1 year
Secondary Progression free survival (PFS) with mpMRI compared to diagnostic TURBT Time from diagnostic test to cancer progression, recurrence, or death. up to 5 years
Secondary Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy up to 5 years
Secondary Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI). up to 5 years
Secondary Incidence of adverse events with mpMRI versus diagnostic TURBT. up to 5 years
Secondary Patient Quality of Life with mpMRI versus diagnostic TURBT. As assessed by quality of life questionnaires up to 5 years
Secondary Incidence of repeat TURBT. up to 5 years
Secondary Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT in dollars up to 5 years
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