Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

Completed · Phase 2

Conditions studied: Neuroendocrine Tumors, Von Hippel-Lindau Syndrome, Hippel-Lindau Disease

In brief

Background: \- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs. Objectives: \- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas. Eligibility: \- Adults over 10 years old with a suspected NET or family history of NET. Design: * Participants will be screened with a medical history and physical exam, and have a blood test. * Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images. * A standard computed tomography (CT) scan of the chest, abdomen, and pelvis. * An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT. * A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes. * Researchers will compare images from the three scans. * Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.

Key facts

Study ID

NCT01967537

Run by

National Cancer Institute (NCI)

People needed

341

Starts

2013-10-18

Expected to finish

2018-03-12

Last updated by the study team

2019-11-19

Who can join

Age: 10 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients unwilling to undergo serial non-invasive imaging.
• Pregnant or lactating women: Pregnant women are excluded from this study because the effects of (68)Ga-DOTATATE in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of
• (68)Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least one day if the mother receives (68)Ga-DOTATATE.
• Patients that have recognized concurrent active infection,
• Patients with the use of any investigational product or device, excluding 18F-dihydroxyphenylalanine (F-DOPA) scans, within 30 days prior to dosing.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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