Recruiting
Early Phase 1

Virtual Histology

Sponsor:

Jodi Maranchie

Code:

NCT04369560

Conditions

Urinary Bladder Neoplasms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging

Gadobutrol intravesical administration (4mM)

Ferumoxytol intravesical administration (5 mM)

Study Details

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

Study ID

NCT04369560

Start date

May 23, 2025

Status verified date

Dec, 2025

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 to 90 years of age
2. Able to understand and willing to sign a written informed consent document
3. 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.
4. Performance status of ECOG 0 or 1
5. 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 Criteria:

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

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Magnetic Resonance Imaging

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.

Interventions

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.

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).

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.

Primary outcome measure

  • Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Brieanna Marino, MS

(412) 647-8258rowlesbm@upmc.edu

Locations

UPMC Hillman Cancer Center - Dept of Urology

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Brieanna HC Marino, MS

(412) 647-8258rowlesbm@upmc.edu

More Information

Sponsor

Jodi Maranchie

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • TURBT
  • Complete Cystectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jodi Maranchie on 2025-12-17.