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

Andrei Iagaru

Status

Conditions: Carcinoid Tumors; Other Neuroendocrine Tumors; Islet Cell (Pancreatic NET)

Treatments: Drug: 68Ga-DOTA TATE

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01980732

26988

NET0017

Details and patient eligibility

About

The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.