89Zr-DFO-Atezolizumab PET/CT for the Diagnosis of Locally Advanced or Metastatic Renal Cell Cancer

Inclusion Criteria

• Patients with suspected renal cell carcinoma with planned surgery or patients with metastatic renal cell cancer (RCC) and a tissue diagnosis (in standard clinical practice, biopsy is not routinely performed in patients who will be having surgery)
• Ability to understand and the willingness to sign a written informed consent
• Patient must be able to lie still for a 30 to 60 minute PET/CT scan
• One of the following: * Cohort 1: Patients with locally advanced RCC planned for nephrectomy determined to be a high risk of recurrence, defined by presence of at least clinical T2 or TxN1, OR patients with metastatic RCC for whom treatment with metastasectomy is planned by the treating physician. * Cohort 2: Patients with metastatic RCC for whom IO therapy is planned
• Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of 89Zr-DFO-atezolizumab administration. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining 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

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to atezolizumab or any other chimeric or humanized antibodies
• 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
• Significant autoimmune disease requiring treatment with either prednisone (or steroid equivalent) at a dose > 10 mg/day or other immunosuppressive agents (replacement steroid therapy is acceptable).
• Any patient for whom immune checkpoint inhibitor therapy would be contraindicated for other reasons. Patients with adverse reactions to immune checkpoint inhibitor (ICI) therapy may undergo second 89Zr-DFO-Atezolizumab injection and PET/CT at the discretion of the treating physician considering that the dose of antibody represents 1% of a single therapeutic dose and therefore unlikely to cause adverse events (AE)
• Subjects unable to provide informed consent
• Subjects who are claustrophobic or have 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 lbs)