Virtual Histology of the Bladder Wall for Bladder Cancer Staging

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jodi Maranchie
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ferrosoferric Oxide

Criteria

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