Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC

Summary: The goal of this clinical research study is to use 68GA-DOTATOC instead of the standard-of-care 111-In-pentetreotide as a tracer chemical during PET/CT scans for diagnosing neuroendocrine tumors. A tracer is injected into participant's bloodstream to help the study doctor see possible tumors.

Detailed description: Study Scans:
  If participant is eligible to take part in this study, participant will have a PET/CT scan.
  Before the PET/CT scan, participant will receive 68GA-DOTATOC by injection. The scan will last up to an hour.
  If participant's regular doctor thinks more PET/CT scans are needed, participant will also receive 68GA-DOTATOC before each of these scans. Usually, these will be performed every 4-6 months.
  Length of Study:
  Participant's active participation on this study will be over after participant's last PET/CT scan.
  Follow-Up:
  Participant will be called by the study staff 24 hours after participant received 68GA-DOTATOC and again 30 days later. Participant will be asked how participant is doing and if participant is having any side effects. The phone call should last about 5-10 minutes. Participant's medical record may be reviewed after the scans for the purposes of the study.
  This is an investigational study. 68GA-DOTATOC is an investigational PET/CT tracer. It is not FDA approved as a PET/CT tracer.
  Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility: Inclusion Criteria:
  1. Patients diagnosed or suspected to have NET, who require 111In-pentetreotide imaging for clinical indications
  2. Subjects with a high risk of NET because of familial predisposition, and also have clinical findings which require radiolabeled somatostatin imaging
  3. Other somatostatin-positive tumors for which 111In -pentetreotide has been used successfully, such as adult meningiomas
  4. 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
  5. 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
  6. Other NET subjects, whether asymptomatic or symptomatic, sporadic or familial, such as VHL and MEN1, will also be included.
  Exclusion Criteria:
  1. Pregnant or lactating women: 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
  2. Lactation should be suspended 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
  3. Subjects with contraindications to the use of 111In -pentetreotide
  4. Known severe allergy or hypersensitivity to oral contrast precludes administration of oral contrast only.
  5. Patients with a body weight of 400 pounds or more, or a 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.
  6. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.

Relevance to patient case: not relevant