Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.