comparative study of sensitivity of ga-dotatoc pet vs octreoscan spect + ct

Conditions: Adult Medulloblastoma; Childhood Medulloblastoma; Neuroblastoma; Neuroendocrine Tumor; Somatostatinoma

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.

primary objectives: i. to compare efficacy of \[68ga\]-dota-tyr3-octreotide (68ga-dotatoc) (gallium ga 68-edotreotide) pet/ct with octreoscan (indium in 111 pentetreotide) + high-resolution, contrast-enhanced ct for diagnosis and staging in patients with somatostatin receptor expressing tumors. outline: patients receive gallium ga 68-edotreotide intravenously (iv) and undergo pet/ct scan. within 120 days, patients undergo standard indium in 111 pentetreotide contrast-enhanced ct or mri scan. patients may also undergo a second gallium ga 68-edotreotide pet/ct scan within 3-6 months if the lesions of the first scan cannot be confirmed.

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

Keywords: neuroendocrine tumor ga-dotatoc pet imaging