Clinical Trial Details
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NCT01619865 : Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide
AgesMin: 2 Years Max: N/A
Inclusion Criteria:

- Signed informed consent

- Age greater than or equal to 2 years

- Known or suspected somatostatin receptor positive tumor such as carcinoid;
neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting
evidence may include MRI, CT, biochemical markers, and or pathology report.

- Karnofsky performance status or Lansky Play Scale status of greater than 50 (or
ECOG/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.

Exclusion Criteria:

- Subject weighs 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,

- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Does the subject have any additional medical condition, serious intercurrent illness,
or other extenuating circumstance that, in the opinion of the Investigator, may
significantly interfere with study compliance?
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