Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

Inclusion Criteria

• •1. Male and female patients ≥18 years of age
• •2. Patients must have the ability to understand and sign an approved informed consent form (ICF)
• •3. Patients must have the ability to understand and comply with all protocol requirements.
• •4. Subjects should satisfy the following criteria:
• •1\) For the Phase 2 (dose optimization) portion of the study: ccRCC patients with at least one suspected metastatic lesion identified by conventional imaging scans at the time of enrolling in the study 2) For the Phase 3 portion of the study: Patients must be suspected of having or be at high risk for developing metastatic disease. This patient population is generally defined as one of the following:
• •1. Newly diagnosed ccRCC patients or post- nephrectomy/post-partial nephrectomy patients with radiographically suspected ccRCC metastatic disease by conventional imaging (CI) planned for biopsy to confirm metastatic disease
• •2. T2B-T4, N0, M0 as assessed by conventional imaging (CI) at initial staging pre-nephrectomy/pre-partial nephrectomy
• •3. Confirmed ccRCC with high risk of metastatic recurrence post nephrectomy pT1b or higher with G3-4 N0( or pNX where clinically N0)M0. Patients must be N0, M0 on the follow up CI not more than 60 days prior to piflufolastat F18 scan
• •4. Patients with new radiographically suspected oligometastatic ccRCC (up to 5 metastatic lesions at presentation) planned for nephrectomy or biopsy for lesion verification of at least one suspected metastatic lesion
• •5\. Completed staging evaluation with baseline conventional imaging (contrast-enhanced CT or contrast-enhanced MRI of the chest, abdomen, and pelvis, or skull base to mid thigh FDG PET)less than or equal to 60 days prior to piflufolastat F 18 PET/CT (Day 1). If baseline conventional imaging was performed outside of the 60-day window, it can be repeated during the screening period provided that there are at least 24 hours between conventional imaging and piflufolastat F 18 (Day 1). Conventional imaging must be available for central evaluation.
• •6\. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• •7\. Patients with life expectancy of at least 6 months as determined by the investigator or treating physician.