Bladder Cancer Clinical Trial

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

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).

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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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

30

Study ID:

NCT06335667

Recruitment Status:

Not yet recruiting

Sponsor:

University of California, Irvine

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There is 1 Location for this study

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Chao Family Comprehensive Cancer Center University of California, Irvine
Orange California, 92868, United States More Info
Nataliya Mar, MD
Contact
877-827-8839
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

30

Study ID:

NCT06335667

Recruitment Status:

Not yet recruiting

Sponsor:


University of California, Irvine

How clear is this clinincal trial information?

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