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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Treatments: Somatostatin

Criteria

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.