Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
Condition: Neuroendocrine Tumors; Carcinoid Tumors; Neuroblastoma; Medulloblastoma
MeSH terms: Neoplasms; Neuroblastoma; Neuroendocrine Tumors; Medulloblastoma; Carcinoid Tumor
Intervention: 68Ga-DOTATOC PET/CT
Intervention description: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
Intervention MeSH terms: Edotreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      Participants in this study have been diagnosed with a tumor such as a carcinoid,
      neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which
      carry somatostatin receptors.

      The purpose of this research study is to see if the tumor can be identified using a special
      procedure called a positron emission tomography (PET) scan and how the results of this
      imaging procedure will change the management of the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent

          2. Age ≥ 6 months

          3. Histologically diagnosed neuroendocrine tumor or other tumor with probable
             somatostatin receptors subtype 2

          4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO
             equivalent)

          5. Subject is male; or is a female who is either surgically sterile (has had a documented
             bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years
             without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test
             (with the results known prior to investigational product administration) is negative.
             A negative pregnancy test will be required for all female subjects with child bearing
             potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an
             obstetrician will be consulted to determine if she is/is not capable of becoming
             pregnant. Female must also be non-lactating.

        Exclusion Criteria:

          1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not
             be able to fit inside the imaging machines) or otherwise cannot be safely fit into the
             imaging system.

          2. Inability to lie still for the entire imaging time (due to cough, severe arthritis,
             etc.)

          3. Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          4. Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the investigator, may significantly interfere
             with study compliance.

          5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT
             scan.

          6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or
             Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).