Dual-Tracer PET/CT for Imaging in Patients with Neuroendocrine Tumors or Prostate Cancer

Inclusion Criteria

• Adults aged 18 years or greater
• All patients or legal guardians must be willing and able to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with local and institutional guidelines
• Presence of at least 1 measurable lesion ≥ 1 cm in size
• Patients must be willing to have their clinical records reviewed for at least 24 months after enrollment
• Patients must be willing to lie flat on their back in the PET/CT scanner for up to one hour to allow for the imaging data to be obtained
• Patients must be willing to undergo two separate PET/CT exams on different days within 2 weeks of each other
• Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging. This only applies to arms 1-2, since only males will be included in arm 3 (only males can get prostate cancer)
• ARMS 1-2: Patients with known or suspected somatostatin receptor-positive neuroendocrine tumor (NET) who could be considered for clinical use of DOTATATE PET/CT imaging under the approved indications for use of this radiopharmaceutical according to published appropriate use criteria. These indications include: initial staging after the histologic diagnosis of NET; evaluation of an unknown primary; evaluation of a mass suggestive of NET not amenable to endoscopic or percutaneous biopsy; staging of NET before planned surgery; monitoring of NET seen predominantly on somatostatin receptor (SSTR) PET; evaluation of patients with biochemical evidence and symptoms of a NET; evaluation of patients with biochemical evidence of a NET without evidence on conventional imaging or a prior histologic diagnosis; restaging at time of clinical or laboratory progression without progression on conventional imaging; and new indeterminate lesion on conventional imaging with unclear progression
• ARM 3: Patients with known or suspected prostate cancer who could be considered for clinical use of PSMA PET/CT imaging under the approved indications for use of this radiopharmaceutical, including: patients with suspected metastasis and patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Exclusion Criteria

• Patients with known intolerance or hypersensitivity to any somatostatin analogs will be excluded from the study arms involving DOTATATE (Arms 1-2)
• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
• Patients who require monitored anesthesia for PET/CT scanning
• Patients who are too claustrophobic to undergo PET/CT scanning
• Patients who exceed the 450 pound (lb.) weight limit of the PET/CT scanner
• Patients who are pregnant or currently breast feeding