68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Inclusion Criteria:

- Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by
111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated

- At least 18 years of age

- Able to provide informed consent

- Karnofsky performance score greater than 50

- Females of childbearing potential must have a negative pregnancy test at
screening/baseline

Exclusion Criteria:

- Serum creatinine > 2.0 mg/dL

- Hepatic enzyme levels more than 3 times upper limit of normal

- Known severe allergy or hypersensitivity to IV radiographic contrast

- Use of any other investigational product or device within 30 days prior to dosing, or
known requirement for any other investigational agent prior to completion of all
scheduled study assessments

- Patients with a body weight of 400 pounds or more or not able to enter the bore of
the PET/CT scanner due to BMI, because of the compromise in image quality with CT,
PET/CT, and MRI that will result

- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
etc.)

- Inability to complete the needed investigational standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Recognized concurrent active infection

- Previous systemic or radiation treatment for another cancer of any type within the
last 2 years

- Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the Investigator, may significantly interfere
with study compliance