What this study is
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 location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.
What's being tested
- Fiducial marker placement
Intervention · PROCEDURE
placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
- Multiparametric MRI (mpMRI)
Intervention · DIAGNOSTIC TEST
In this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.
Study details
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Bladder Cancer · Urinary Bladder Neoplasm · Urologic Neoplasms · Neoplasms · Urinary Bladder Diseases
- Enrolling
- 60 people
- Starts
- 2020-07-01
- Est. completion
- 2026-06-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openCedars-Sinai Medical Center (CSMC)
Los Angeles, California, United States
RecruitingUniversity of California Los Angeles
Los Angeles, California, United States
- Jackie Hernandez, CCRP · Contact310-267-8991jhernandez@mednet.ucla.edu
RecruitingHarvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
- Sarah Stec · ContactSSTEC@mgh.harvard.edu
Recruiting
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID IIT2017-12-Garcia-FMBRT
Principal investigator
Maurice Garcia, MD
Cedars-Sinai Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.