mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer

NCT ID: NCT06335667

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2030-04-30

Brief 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).

Conditions

Urothelial Bladder Cancer; Muscle-Invasive Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

mpMRI + Diagnostic TURBT

Group Type: EXPERIMENTAL

mpMRI + Diagnostic TURBT

Intervention Type: DIAGNOSTIC_TEST

mpMRI in addition to the TURBT surgical procedure

Interventions

mpMRI + Diagnostic TURBT

mpMRI in addition to the TURBT surgical procedure

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Nataliya Mar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nataliya Mar, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

marn@hs.uci.edu

Facility Contacts

Nataliya Mar, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 23-72

Identifier Type: OTHER

Identifier Source: secondary_id

4565

Identifier Type: -

Identifier Source: org_study_id