An Investigational Scan ([18F]PT2385 PET/CT) for the Imaging of Kidney Cancer

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory biopsy).
• Ability to lie still for a 30 to 60 minute PET/CT scan.
• Patient age over 18 years.
• One of the following: * Cohort 1. Patients with suspected RCC planned for surgery. * Cohort 2. Patients with metastatic clear-cell (cc)RCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is acceptable in lieu of the biopsy). * Cohort 3. Patients with VHL syndrome with RCC, central nervous system (CNS) hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
• Patients with liver dysfunction will be considered “patients of special interest” and enrollment is allowed with or without criteria outlined. Liver dysfunction is defined clinically and is typically supported by abnormalities in imaging or laboratory studies (alanine / aspartate amino-transferase, bilirubin, alkaline phosphatase, or international normalized range [INR] for prothrombin time).
• Women of childbearing potential must agree to undergo and have documented a negative pregnancy test on the day of [18F]PT2385 administration. * A female of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria

• Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Claustrophobia or other contraindications to PET/CT.
• Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed (> 200 kg or 440 pounds [lbs]).
• For cohort 2 patients, lack of suitable sites for mandatory biopsy. For example, patients with metastatic disease restricted to the lungs that would require percutaneous biopsies with associated risk of bleeding and pneumothorax will be excluded.