Using gold markers and advanced MRI to improve bladder cancer treatment
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
NA · Cedars-Sinai Medical Center · NCT04442724
This study is testing if tiny gold markers and a new type of MRI can help doctors better target and treat bladder cancer while preserving the bladder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Drugs / interventions | immunotherapy, Radiation |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT04442724 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of small 24-K gold fiducial markers implanted around bladder tumors to help radiation oncologists accurately target the tumor during treatment. It also evaluates a new multiparametric MRI (mp-MRI) technology for earlier and more precise detection of bladder cancer that may not be visible through traditional methods. Patients with localized muscle-invasive bladder cancer who choose bladder preservation with tri-modal therapy will be enrolled. The study aims to enhance the effectiveness of bladder-sparing treatments and assess the accuracy of mp-MRI imaging in detecting bladder cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with localized muscle-invasive bladder cancer who are electing for bladder preservation and are eligible for chemoradiation.
Not a fit: Patients with non-muscle invasive bladder cancer or those not planning to undergo chemoradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and targeted treatment for bladder cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using fiducial markers and advanced imaging techniques for cancer treatment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern. * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min * Ability to understand and willingness to sign a written informed consent * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed * Known distant metastatic disease (e.g. pulmonary or hepatic metastases) * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection) * Planned (or prior history of) definitive bladder irradiation * Intravesical chemo- or biologic therapy within 6 weeks of first treatment * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study * Pregnant or nursing women are excluded * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment * Individuals with severe renal failure and cannot receive MRI contrast
Where this trial is running
Los Angeles, California and 2 other locations
- Cedars-Sinai Medical Center (CSMC) — Los Angeles, California, United States (RECRUITING)
- University of California Los Angeles — Los Angeles, California, United States (RECRUITING)
- Harvard School of Medicine/Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Maurice Garcia, MD — Cedars-Sinai Medical Center
- Study coordinator: Laura Sarmiento, CCRP
- Email: laura.sarmiento@cshs.org
- Phone: 310-423-4295
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.
Conditions: Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases, Fiducial marker, Fiducial marker guided technique