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Protocol No. UW17104

Principal Investigator Cho, Steven

Phase II

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed; Institutional

Title Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies

Objective The purpose of this research is to determine if 18F-DCFPyL PSMA PET/CT scans are better for monitoring patients being treated for RCC than the standard scans. The 18FDCFPyL PSMA PET tracer has been shown to be better at finding cancer that has spread to other parts of the body. Knowing where the tumors are makes it easier to monitor how effective treatment is. This tracer is “investigational” which means it is not FDA approved. However, we have obtained permission from the FDA to use this agent for this research study

Treatment The first visit will be scheduled to be done before your surgery; the second visit will be scheduled after your surgery but before your start treatment; the third visit will be scheduled after you complete treatment; and the fourth visit will be scheduled if the cancer recurs or within 2 years after the start of treatment

Key Eligibility Inclusion Criteria:
  • Patients diagnosed with metastatic clear cell RCC as proven by biopsy.
  • Adults, 18 years of age or older.
  • Surgical candidates who have clinical indication for nephrectomy and standard-of-care biopsy of metastatic disease followed by standard of care systemic anti-angiogenesis treatment regimen
  • Have consented to participate in the UWCCC Biobank.
  • Clinically classified as either A) M1 Tany Nany or B) m0 Tany N1 but unable to complete excise LN
    Exclusion Criteria
  • Patients who have received prior RCC systemic therapies
  • Prior history of prostate cancer
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
  • Unable to lie flat during or tolerate PET/CT
  • Serum creatinine > 2 times the upper limit of normal

  • Applicable Disease Sites Kidney

    Status Open

    Participating Institutions UW Hospital and Clinics