Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
Condition: Adult Medulloblastoma; Childhood Medulloblastoma; Neuroblastoma; Neuroendocrine Tumor; Somatostatinoma
MeSH terms: Neuroblastoma; Neuroendocrine Tumors; Medulloblastoma; Somatostatinoma
Intervention: gallium Ga 68-edotreotide; positron emission tomography/computed tomography; indium In 111 pentetreotide; computed tomography; contrast-enhanced magnetic resonance imaging
Intervention description: Given IV; Undergo gallium Ga 68-edotreotide PET/CT scan; Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan; Undergo indium In 111 pentetreotide contrast-enhanced CT scan; Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Intervention MeSH terms: Octreotide; Edotreotide; Indium-111-octreotide; Somatostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Neuroendocrine Tumor; Ga-DOTATOC PET; Imaging

Summary:

      This clinical trial studies gallium Ga 68-edotreotide positron emission tomography
      (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus
      contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other
      somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga
      68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive
      neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective
      as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of
      patients with neuroendocrine tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other
             somatostatin receptor positive tumor

          -  Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off
             immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT

          -  Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern
             Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

          -  Subject is male; or is a female who is either pre-menarchal, surgically sterile (has
             had a documented bilateral oophorectomy and/or documented hysterectomy),
             postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential
             for whom a serum pregnancy test (with the results known prior to investigational
             product administration) is negative; a negative serum 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 capable of becoming pregnant

          -  No therapy other than Sandostatin since last Octreoscan + diagnostic CT

          -  Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or
             metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

        Exclusion Criteria:

          -  Pregnancy or breast feeding

          -  Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last
             Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous
             Sandostatin is allowed

          -  Medical condition uncontrolled by treatment making completion of study unlikely

          -  Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able
             to fit inside the imaging machines)

          -  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.)

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the investigator, may significantly interfere
             with study compliance