Virtual Histology of the Bladder Wall for Bladder Cancer Staging

NCT04369560 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HCC 20-054
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder Neoplasms

Keywords

TURBT; Complete Cystectomy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection

  The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.

  4 weeks

Secondary Outcomes (2)

• Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor

  4 weeks

• Rate of Adverse Events

  2 years

Study Arms (1)

Magnetic Resonance Imaging

EXPERIMENTAL

Prior to planned surgical resection, subjects will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast 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 a second, single breath hold post-contrast image.

Diagnostic Test: Magnetic Resonance Imaging; Drug: Gadobutrol intravesical administration (4mM); Drug: Ferumoxytol intravesical administration (5 mM)

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

Magnetic Resonance Imaging

Gadobutrol intravesical administration (4mM) DRUG

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).

Also known as: Image result for other names for Gadobutrol Gadavist

Magnetic Resonance Imaging

Ferumoxytol intravesical administration (5 mM) DRUG

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.

Also known as: FERAHEME

Magnetic Resonance Imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jodi Maranchie: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Hillman Cancer Center - Dept of Urology

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Magnetic Resonance Imaging; Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Jodi K Maranchie, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brieanna Marino, MS

CONTACT

(412) 647-8258; rowlesbm@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Diagnostic Test - Magnetic Resonance Imaging

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: May 23, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)