Virtual Histology of the Bladder Wall for Bladder Cancer Staging

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

January 6, 2021

Primary Completion Date

January 30, 2027

Study Completion Date

December 30, 2027

Conditions
Urinary Bladder Neoplasms
Interventions
DIAGNOSTIC_TEST

Magnetic Resonance Imaging

60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.

DRUG

Gadobutrol intravesical administration (4mM)

A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).

DRUG

Ferumoxytol intravesical administration (5 mM)

An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.

Trial Locations (1)

15232

RECRUITING

UPMC Department of Urology, Pittsburgh

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Jodi Maranchie

OTHER