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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