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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

Who can join

Ages 18 to 90 · All sexes

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

About the study

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.

What is being tested

• Magnetic Resonance Imaging (diagnostic test)
• Gadobutrol intravesical administration (4mM) (drug)
• Ferumoxytol intravesical administration (5 mM) (drug)

Sponsor: Jodi Maranchie · Participants: 42 · Started: May 23, 2025

Contact the study team

• Brieanna Marino, MS · Phone: (412) 647-8258

Official record on ClinicalTrials.gov — NCT04369560

Locations in the U.S.

Conditions

• Bladder Cancer

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.