Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Launched by JODI MARANCHIE · Apr 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of MRI scan to help doctors better understand the stage of bladder cancer before surgery. It involves using a special contrast solution that is placed in the bladder through a temporary catheter. The aim is to see how well this new MRI method works in identifying the presence and depth of bladder tumors. The trial is looking for adults aged 18 to 90 who have been diagnosed with specific types of bladder tumors and are scheduled for surgery.

If you participate, you will have one MRI scan that includes two parts: the first is a regular image, and the second is taken after the contrast solution is placed in your bladder. The process should be done safely and aims to improve how bladder cancer is staged. It's important to note that certain conditions, like severe allergies to the contrast agents or having certain medical devices, may prevent you from joining the study. This trial is currently recruiting participants, and your involvement could contribute to better treatment methods for bladder cancer in the future.

Gender

ALL

Eligibility 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