Virtual Histology of the Bladder Wall for Bladder Cancer Staging

This study is looking at a new way to use Magnetic Resonance Imaging (MRI) to help doctors understand how far bladder cancer has spread before surgery. You would have a special MRI scan where two contrast agents, Gadobutrol and Ferumoxytol, are placed into your bladder through a temporary catheter. Doctors will then compare these MRI images to what they find during your surgery to see how accurate the MRI is at determining the cancer's stage. This study is for people aged 18 to 90 who have a bladder tumor identified by cystoscopy (a procedure to look inside the bladder) and are scheduled for a TURBT (Transurethral Resection of Bladder Tumor) or have muscle-invasive bladder cancer and are scheduled for radical cystectomy (removal of the bladder). The study plans to enroll 42 participants, but its current status is unclear.

Study design
This is a Phase Ib interventional study involving 42 participants to test the safety and performance of a new MRI protocol.
What's involved
You would undergo a single MRI scan, which includes a pre-contrast image, instillation of a contrast solution into your bladder, and then a post-contrast image. This MRI would be performed 1 to 6 days before your scheduled surgery.
Compensation
Not stated in the trial record.
Follow-up
The accuracy of the MRI assessment will be measured at 4 weeks after tumor resection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04369560

Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Recruiting
EARLY_PHASE1Ages 18–90InterventionalDiagnostic
Jodi Maranchie
~42 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Magnetic Resonance ImagingGadobutrol intravesical administration (4mM)Ferumoxytol intravesical administration (5 mM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection
Measured over 4 weeks
Urinary Bladder Neoplasms

NCT04369560

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UPMC Hillman Cancer Center - Dept of Urology

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jodi K Maranchie, MD · PRINCIPAL_INVESTIGATOR · Associate Professor

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  • Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection4 weeks

    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.