A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy

Inclusion Criteria10

• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Axumin in pediatric patients, patients \<18 years of age are excluded from this study.
• ECOG performance status ≤2 (Karnofsky ≥60%,).
• Willingness to participate in the study and ability to provide written informed consent.
• Patients must have documented brain metastatic lesion(s) in the medical record.
• On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is allowed. Immunotherapy and other treatment regimens are determined by treating physicians as per standard clinical practice.
• Patients with at least one metastatic brain lesion showing suspected pseudoprogression on SoC imaging modality (such as CT, or MRI, or FDG PET-CT, or DOTATATE PET/CT, or PSMA PET/CT).
• The suspected pseudoprogresson can be determined by imaging physician (such as neuroradiologists and/or nuclear medicine physicians) and/or treating physicians (usually are oncologists). Ideally, the target/index lesion should be measurable (at discretion of investigator imaging physicians) and feasible for series follow up and comparison at imaging physician's discretion.
• Ability and willingness to undergo another follow up Fluciclovine PET/CT, usually within 60 days of SoC follow up imaging modality.
• Ability and willingness to undergo biopsy if needed per standard of care.
• Estimated life expectancy of at least 3 months as determined by the investigator or treating physician.