Actively Recruiting
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Led by Jodi Maranchie · Updated on 2025-12-17
42
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
J
Jodi Maranchie
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Able to understand and willing to sign informed consent
- Presence of papillary bladder tumor scheduled for transurethral resection or muscle invasive bladder cancer confirmed by biopsy and suitable for surgery
- Performance status of ECOG 0 or 1
- Normal kidney function defined as creatinine less than 1.5 times institutional upper limit or creatinine clearance ≥ 50 mL/min/1.73 m2
You will not qualify if you...
- Severe allergic reaction to gadobutrol or ferumoxytol
- Severe claustrophobia preventing MRI completion
- Presence of MRI-incompatible implanted devices or pacemakers
- Known or suspected metastatic bladder cancer
- Women who are pregnant, breastfeeding, or planning to become pregnant
- Untreated urinary tract infection
- Urethral stricture preventing catheter placement
- Any other condition deemed high risk by the treating physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center - Dept of Urology
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
B
Brieanna Marino, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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