GA-69 DOTA-TATE Imaging of Somatostatin R+ Malignancies

PRIMARY OBJECTIVES:

I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the
delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management
decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70
minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50
minutes.

After completion of study, patients are followed up for 2 weeks.

Inclusion Criteria:

- Known or suspected somatostatin receptor positive tumor such as carcinoid;
neuroendocrine tumor; neuroblastoma; pheochromocytoma; supporting evidence may include
MRI, CT, biochemical markers, and or pathology report

- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)

- Not pregnant; a negative serum pregnancy test is required for all female subjects with
child-bearing potential

- Ability to understand a written informed consent document, and the willingness to sign
it

Exclusion Criteria:

- Hepatic enzymes 5 times greater than the upper limits of normal

- Serum creatinine > 3.0 mg/dL (270 uM/L)

- Patients exceeding the weight limitations of the scanner or are not able to enter the
bore of the PET/CT scanner due to body mass index (BMI)

- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical
protocol

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

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

- Recognized concurrent active infection

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

- 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