Status:
RECRUITING
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Urinary Bladder Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor locati...
Detailed Description
This study of fiducial markers in patients with localized muscle-invasive bladder cancer will enroll patients electing bladder preservation with tri-modal therapy. 24-K gold fiducial markers will be ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04442724
Start Date
July 1 2020
End Date
June 30 2026
Last Update
August 14 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, United States, 90048
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
Harvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114