Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
Condition: Neuroendocrine Tumors; Von Hippel-Lindau Syndrome; Hippel-Lindau Disease
MeSH terms: Neuroendocrine Tumors; Von Hippel-Lindau Disease
Intervention: 68Gallium DOTATATE; Radio-guided surgery
Intervention description: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.; Using 68Gallium DOTATATE
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 10 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: NET; MEN1; Von Hippel Lindau (VHL); Surgical Resection; Somatostatin Receptor Status

Summary:

      Background:

      - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The
      only treatment for NETs is surgery, but most are found when they are too advanced for
      surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can
      be successful. They want to test if the study drug can be used along with imaging devices to
      detect NETs.

      Objectives:

      - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown
      primary and metastatic NETs in the gastrointestinal system and pancreas.

      Eligibility:

      - Adults over 10 years old with a suspected NET or family history of NET.

      Design:

        -  Participants will be screened with a medical history and physical exam, and have a blood
           test.

        -  Participants will undergo three scans. For all of these, a substance is injected into
           their body, they lie on a table, and a machine takes images.

        -  A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.

        -  An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.

        -  A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected
           into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40
           minutes a large, donut-shaped device takes images of the body. The entire session takes
           90 to 120 minutes.

        -  Researchers will compare images from the three scans.

        -  Participants will have 1 follow-up visit each year for 5 years. At this visit, they will
           have a medical exam, blood taken, and a CT scan.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients with (any one of #1, #2, and/or #3):

               1. Suspicion of neuroendocrine tumors (NET) on axial imaging (computed tomography
                  (CT)/magnetic resonance imaging (MRI)/fluorodeoxyglucose (FDG) positron emission
                  tomography (PET) and/or

               2. biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated
                  levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase,
                  vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin,
                  somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin,
                  C-peptide (proinsulin), glucagon and/or

               3. familial predisposition to NET in patients with multiple endocrine neoplasia type
                  1 (MEN1) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with
                  biochemical or anatomic imaging evidence of disease).

          -  Age greater than or equal to 10 years of age.

          -  For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR
             patient has had a hysterectomy.

          -  Patients must be willing to return to National Institutes of Health (NIH) for
             follow-up.

          -  Ability of subject or 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
             document indicating that they are aware of the investigational nature of this study.

        EXCLUSION CRITERIA:

          -  Patients unwilling to undergo serial non-invasive imaging.

          -  Pregnant or lactating women: Pregnant women are excluded from this study because the
             effects of (68)Ga-DOTATATE in pregnancy are not known. Because there is an unknown but
             potential risk for adverse events in nursing infants secondary to administration of

             (68)Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least one
             day if the mother receives (68)Ga-DOTATATE.

          -  Patients that have recognized concurrent active infection,

          -  Patients with the use of any investigational product or device, excluding
             18F-dihydroxyphenylalanine (F-DOPA) scans, within 30 days prior to dosing.