Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

In this study, we propose to use a well-established PET isotope, 68-Gallium (68Ga), bound to
a somatostatin analogue, DOTA-octreotate, or DOTATATE, which has high affinity for the
somatostatin receptor type 2 (SSTR2). Most gastro-entero-pancreatic (GEP) NETs express SSTR2
on their cell surfaces; when the radiolabeled SSTR2 analogue binds to these receptors, the
radioactive molecule is internalized and transported to the tumor cell nucleus, thus
concentrating the radioactivity and improving the signal-to-noise ratio on the PET scan,
particularly as the background rapidly clears. This internalization, combined with the
improved physical principles of PET imaging, shorter half-life of the 68Ga (68 minutes vs.
about three days for 111In), improved radiation dosimetry, faster scanning, and lower cost
results in a greatly improved scan for diagnosis, staging and restaging of NET disease
compared to conventional 111In-octreotide imaging. Additionally, 68Ga-DOTATATE PET/CT
scanning can be performed in 1.5 hours from injection of the radiopharmaceutical to
completion of the scan, vs. 2-3 days for 111In-octreotide imaging.

Inclusion Criteria:

- Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence.

- At least 18 years of age.

- Patient or patient's legally acceptable representative cognitively provides written
informed consent.

- Able to provide informed consent.

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

Exclusion Criteria:

- 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.

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

- Recognized concurrent active infection.

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