Using MRI with contrast to assess bladder cancer staging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase Ib study evaluates the safety and effectiveness of a new MRI protocol enhanced with a contrast solution for staging bladder cancer before surgical procedures. It involves 42 patients, split into two groups: those scheduled for transurethral resection of bladder tumors and those for radical cystectomy due to muscle invasive disease. Participants will undergo MRI scans before and after the administration of a contrast agent to determine tumor presence and depth of invasion. The imaging results will be analyzed by radiologists who are unaware of the patients' pathology results.

Why it matters

Who can join: the full rules

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

Where it's running

• UPMC Hillman Cancer Center - Dept of Urology
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jodi K Maranchie, MD — Associate Professor
• Study coordinator: Brieanna Marino, MS
• Email: rowlesbm@upmc.edu
• Phone: (412) 647-8258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.