Using MRI with contrast to assess bladder cancer staging
Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
This study is testing a new type of MRI with a special contrast solution to see if it can help doctors better understand the stage of bladder cancer in patients before surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04369560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with confirmed bladder tumors scheduled for surgical intervention.
Not a fit: Patients with severe hypersensitivity to the contrast agents or those with known metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of bladder cancer staging, leading to better treatment decisions and outcomes for patients.
How similar studies have performed: While this specific approach is novel, similar imaging techniques have shown promise in other cancer staging studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.