Table 1.

Study Eligibility Criteria

Factors Determining Eligibility
Inclusion criteria
Patient with any one of the following:
Suspicion of NET on imaging (CT/MRI/18F-FDG PET); and/or
Biochemical evidence of NET (serum/urinary) on the basis of elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon; and/or
Familial predisposition to NET in patient with clinical or genetic proof of mutation in MEN1 or VHL (symptomatic and/or asymptomatic case; with biochemical or anatomic imaging evidence of disease).
Age ≥ 18 years.
For women: Negative urine pregnancy test or postmenopausal for at least 2 years or if patient has had a hysterectomy.
Patient must be willing to return to NIH for follow-up.
Ability of patient or legally authorized representative (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 he or she is aware of the investigational nature of this study.
Exclusion criteria
Patient unwilling to undergo serial noninvasive imaging.
Pregnant or lactating woman: Pregnant women are excluded from this study because the effects of 68Ga-DOTATATE in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least 1 day if the mother receives 68Ga-DOTATATE.
Patient has recognized concurrent active infection.
Patient has had the use of any investigational product or device, excluding F-DOPA scans, within 30 days before dosing.

Abbreviations: CT, computed tomography; ¹⁸F-FDG, ⁸F-fluorodeoxyglucose; 5-HIAA, 5-hydroxyindoleacetic acid; MEN1, multiple endocrine neoplasia type 1; MRI, magnetic resonance imaging; NET, neuroendocrine tumor; NIH, National Institutes of Health; PET, positron emission tomography; VHL, von Hippel-Lindau.