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

Inclusion Criteria5

to 90 years of age
Able to understand and willing to sign a written informed consent document
A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.
Performance status of ECOG 0 or 1
Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.

Exclusion Criteria8

Severe hypersensitivity reaction to gadobutrol or ferumoxytol.
Severe claustrophobia that will prevent completion of the MRI study.
Any MRI-non-compatible implanted device, prosthetic or pacemaker.
Known or suspected metastatic disease.
Women with active pregnancy, lactation or plans to conceive
Untreated urinary tract infection
Known urethral stricture disease that would prohibit placement of foley catheter.
Any other conditions considered as unacceptable risk by the treating physician

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.