Using gold markers and advanced MRI to improve bladder cancer treatment

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.