Status:
RECRUITING
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Lead Sponsor:
Jodi Maranchie
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Urinary Bladder Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
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 re...
Detailed Description
Twenty one patients with at least one cystoscopically confirmed papillary bladder tumor, who have been scheduled for Transurethral Resection of Bladder Tumor (TURBT) for surgical extirpation and stagi...
Eligibility Criteria
Inclusion
- 18 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04369560
Start Date
May 23 2025
End Date
December 30 2028
Last Update
December 17 2025
Active Locations (1)
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1
UPMC Hillman Cancer Center - Dept of Urology
Pittsburgh, Pennsylvania, United States, 15232