Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients with Primary or Metastatic Gastrointestinal or Pancreatic Neuroendocrine Tumors

Inclusion Criteria

• Patients with (any one of the following): * Suspicion of NET on axial imaging (CT/magnetic resonance imaging [MRI]/fludeoxyglucose [FDG] PET) and/or * Biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-hydroxyindoleacetic acid [HIAA]), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon and/or * Familial predisposition to NET in patients with multiple endocrine neoplasia type 1 (MEN1) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with biochemical or anatomic imaging evidence of disease)
• For females: negative urine pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
• Patients must be willing to return to National Institutes of Health (NIH) for follow-up
• Ability of subject or legally authorized representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study

Exclusion Criteria

• Patients unwilling to undergo serial non-invasive imaging
• Pregnant or lactating women: pregnant women are excluded from this study; breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATATE
• Patients that have recognized concurrent active infection
• Patients with the use of any investigational product or device, excluding fluorodopa (F-DOPA) scans, within 30 days prior to dosing