68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

This is an expanded access trial for Carcinoid Tumors Read More

Inclusion Criteria:

• Greater than 18 years-old at the time of radiotracer administration
• Provides written informed consent
• Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
• Karnofsky score greater than 50 or ECOG Performance Status 0-2
• Women of childbearing age must have a negative pregnancy test at screening/baseline
• Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

• Less than 18 years-old at the time of radiotracer administration
• Pregnant or nursing
• Serum creatinine >3.0 mg/dL
• Hepatic enzyme levels more than 5 times upper limit of normal.
• Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
• Inability to lie still for the entire imaging time
• 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.