68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors

PRIMARY OBJECTIVES:

I. To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor
imaging for study subjects, where the care provider believes that somatostatin imaging is
clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.

SECONDARY OBJECTIVES:

I. To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine
tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).

II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.

OUTLINE:

Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants
undergo PET/CT scan over 60 minutes.

After completion of study, participants are followed up at 24 hours or within 72 hours, and
at 30 days.

Inclusion Criteria:

- Ability of the subject, or the legally authorized representative (LAR), 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

- All participants must meet one of the following:

- Patients diagnosed or suspected to have neuroendocrine tumors (NET), who require
111In-pentetreotide imaging for clinical indications

- Subjects with a high risk of NET because of familial predisposition, and also
have clinical findings which require radiolabeled somatostatin imaging

- Other somatostatin-positive tumors for which 111In-pentetreotide has been used
successfully, such as adult meningiomas

- Patients with suspected neuroendocrine tumor, unknown primary NET, metastatic
NET, or other tumors, such as meningiomas, in whom the primary physician
considers somatostatin imaging to be clinically indicated

- Other NET subjects, whether asymptomatic or symptomatic, sporadic or familial,
such as Von Hippel-Lindau syndrome (VHL) and multiple endocrine neoplasia type 1
(MEN1), will also be included

Exclusion Criteria:

- Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in
pregnancy are not known; exceptions may be granted only if the expected risk outweighs
the benefit, in the clinical opinion of the attending physician. Pregnancy testing
will follow MD Anderson procedure for diagnostic reagents. Self-reporting is used to
assess pregnancy status. If the subject is unsure about her status, a urine or serum
pregnancy test will be performed before inclusion

- Lactating women are excluded if patient is unwilling to suspend lactation for at least
one day following the administration of 68Ga-DOTATOC to the mother, because of the
unknown but potential risk for adverse events in nursing infants secondary to
administration of the radionuclide to a lactating woman

- Subjects with known contraindications to the use of 111In-pentetreotide

- Known severe allergy or hypersensitivity to oral contrast precludes administration of
oral contrast only

- Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which
precludes their entry into the bore of the PET/CT scanner, because of the resulting
probable compromise in image quality with CT, PET/CT and MRI

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