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

NCT ID: NCT06335667

Condition: Urothelial Bladder Cancer
Muscle-Invasive Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: Keywords:
mpMRI
TURBT
VI-RADS score

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: mpMRI + Diagnostic TURBT
Description: mpMRI in addition to the TURBT surgical procedure
Arm group label: mpMRI + Diagnostic TURBT

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Chao Family Comprehensive Cancer Center University of California, Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Contact:
Last name: Nataliya Mar, MD

Phone: 877-827-8839
Email: ucstudy@uci.edu

Start date: March 27, 2024

Completion date: April 2030

Lead sponsor:
Agency: University of California, Irvine
Agency class: Other

Source: University of California, Irvine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06335667

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