Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01619865 : Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide
PhaseN/A
AgesMin: 2 Years Max: N/A
Eligibility
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,
etc.)

- 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?
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01619865      |      Link to official Clinicaltrials.gov listing
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