Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

This is a prospective, Phase II, single center, open-label study in a total of 200
participants with histologically proven neuroendocrine tumor or other somatostatin receptor
positive tumors. Eligible participants will undergo baseline assessments at enrollment. They
will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a
second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

Inclusion Criteria:

1. Signed informed consent

2. Age ≥ 6 months

3. Histologically diagnosed neuroendocrine tumor or other tumor with probable
somatostatin receptors subtype 2

4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO
equivalent)

5. Subject is male; or is a female who is either surgically sterile (has had a documented
bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years
without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test
(with the results known prior to investigational product administration) is negative.
A negative pregnancy test will be required for all female subjects with child bearing
potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an
obstetrician will be consulted to determine if she is/is not capable of becoming
pregnant. Female must also be non-lactating.

Exclusion Criteria:

1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not
be able to fit inside the imaging machines) or otherwise cannot be safely fit into the
imaging system.

2. Inability to lie still for the entire imaging time (due to cough, severe arthritis,
etc.)

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

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

5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT
scan.

6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or
Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).