68Ga-DOTATATE PET Scan in Neuroendocrine Cancer
Condition: Neuroendocrine Carcinoma
MeSH terms: Neuroendocrine Tumors; Carcinoma, Neuroendocrine
Intervention: 68Ga-DOTATATE PET scan
Intervention description: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuroendocrine; neuroendocrine carcinoma; neuroendocrine tumor; carcinoid; carcinoid tumor; islet cell tumor; APUDoma; Gallium; PET Scan

Summary:

      Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The
      68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and
      resolution specifically for neuroendocrine tumors. The investigators will scan people with
      this cancer and compare it to other conventional imaging methods to see if it improves
      patient care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known diagnosis of neuroendocrine tumor

          -  At least 18 years of age

          -  Able to provide informed consent

          -  Karnofsky score greater than 50

          -  Females of childbearing potential must have a negative pregnancy test at
             screening/baseline

        Exclusion Criteria:

          -  Serum creatinine >3.0 mg/dL (270 μM/L)

          -  Hepatic enzyme levels more than 5 times upper limit of normal.

          -  Known severe allergy or hypersensitivity to IV radiographic contrast.

          -  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.

          -  Patients with a body weight of 400 pounds or more or not able to enter the bore of the
             PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT
             and MRI that will result.

          -  Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
             etc.).

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          -  Recognized concurrent active infection

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance.