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

Trial ID or NCT#

NCT01980732

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Jeffrey Norton, MD
Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)

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Contact

Krithika Rupnarayan
650-736-0959