This clinical trial is evaluating whether a single magnetic resonance imaging scan with contrast agents gadobutrol and ferumoxytol can accurately diagnose the stage of bladder cancer in patients who are scheduled to have a resection (transurethral resection of the bladder tumor [TURBT]) or a complete removal of the bladder (cystectomy). Magnetic resonance imaging is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Gadobutrol and ferumoxytol are contrast agents that are injected into the body and taken up by certain tissues, making the tissues easier to see in imaging scans. Giving gadobutrol and ferumoxytol before magnetic resonance imaging may work better at diagnosing the stage of bladder cancer in patients who are scheduled to have TURBT or a cystectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT04369560.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Jodi Kathleen Maranchie
Phone: 412-605-3019
PRIMARY OBJECTIVES:
I. Evaluate the intermodality agreement between pre-operative clinical staging of bladder cancer by novel contrast mixture (NCM)-magnetic resonance imaging (MRI) with subsequent histopathologic staging of transurethral resection of the bladder tumor (TURBT) specimens.
II. Evaluate the intermodality agreement between preoperative NCM-MRI for bladder cancer (BCa) staging with whole-mount pathologic review of cystectomy specimen.
OUTLINE:
Patients receive gadobutrol and ferumoxytol intravesically and undergo MRI 1-6 days prior to scheduled TURBT or cystectomy on study. Patients also undergo blood and urine collection during screening.
After completion of study intervention, patients are followed up after 3-5 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorJodi Kathleen Maranchie
