RECRUITING

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

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Conditions

Urothelial Bladder CancerMuscle-Invasive Bladder CancermpMRITURBTVI-RADS score

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study

Quick Facts

Study Start:2024-03-27
Study Completion:2030-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06335667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years old or greater at the time of consent.
  2. * Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated urologist performing this procedure.
  3. * ECOG Performance Status of 0-3.
  4. * 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).
  5. * 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.
  1. * Prior TURBT within 120 days of study entry.
  2. * Prior therapy for bladder cancer within 120 days of study entry.
  3. * Inability to tolerate mpMRI or associated contrast.
  4. * Inability to tolerate TURBT or associated anesthesia.
  5. * ECOG Performance Status of 4.
  6. * Female patient who is known to be pregnant or breastfeeding.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
1-877-827-8839
ucstudy@uci.edu
University of California Irvine Medical
CONTACT
marn@hs.uci.edu

Principal Investigator

Nataliya Mar, MD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Nataliya Mar, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27
Study Completion Date2030-04

Study Record Updates

Study Start Date2024-03-27
Study Completion Date2030-04

Terms related to this study

Keywords Provided by Researchers

  • mpMRI
  • TURBT
  • VI-RADS score

Additional Relevant MeSH Terms

  • Urothelial Bladder Cancer
  • Muscle-Invasive Bladder Cancer