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

Summary

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.

Timeline

Start

2013-10-18

Primary completion

2017-12-17

Completion

2018-03-12

Publications

• Background Tsikitis VL, Wertheim BC, Guerrero MA. Trends of incidence and survival of gastrointestinal neuroendocrine tumors in the United States: a seer analysis. J Cancer. 2012;3:292-302. doi: 10.7150/jca.4502. Epub 2012 Jul 1.
• Background Lawrence B, Gustafsson BI, Chan A, Svejda B, Kidd M, Modlin IM. The epidemiology of gastroenteropancreatic neuroendocrine tumors. Endocrinol Metab Clin North Am. 2011 Mar;40(1):1-18, vii. doi: 10.1016/j.ecl.2010.12.005.
• Background Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59. doi: 10.1002/cncr.11105.

Drugs

Indications