RecruitingEarly Phase 1NCT04369560

Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging

Sponsor

Jodi Maranchie

Enrollment

42 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms

Summary

This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special MRI scan using a contrast dye (gadobutrol) can accurately determine how deeply bladder cancer has invaded the bladder wall — a critical piece of information that determines whether the bladder needs to be removed. This "virtual histology" approach may reduce the need for invasive biopsies. **You may be eligible if:** - You are 18 to 90 years old - You have a bladder tumor seen on cystoscopy (a camera exam inside the bladder) that is scheduled for surgical removal (TURBT), OR you have confirmed muscle-invasive bladder cancer being treated with surgery intended to cure - You are in good general health (ECOG 0 or 1) - Your kidney function is adequate **You may NOT be eligible if:** - You have a severe allergy to the MRI contrast agent (gadobutrol) - You cannot undergo MRI for any reason - Your kidney function is too poor to safely receive contrast dye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

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

DRUGGadobutrol 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).

DRUGFerumoxytol 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.