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# FDA Approves Netspot Kit for Locating NET Tumors
- URL: https://www.fdaweb.com/fda-approves-netspot-kit-for-locating-net-tumors/
- Published: 2016-06-01T12:00:00.000Z
- Updated: 2026-09-14T21:06:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135814

FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the body’s neuroendocrine system, according to an agency [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504524.htm?ref=fdaweb.com). They have receptors for somatostatin, a hormone that regulates the endocrine system, and Ga 68 dotatate, a positron emitting somatostatin analog, works by binding to the receptors, it says.

Netspot comes as a sterile, single-dose kit for preparing Ga 68 dotatate injection for intravenous use. “The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs,” FDA says. “This uptake can also be seen in a variety of other tumor types or other pathologic conditions, or might occur as a normal variant. The uptake of Ga 68 dotatate may need to be confirmed by histopathology or other assessments.”

Approval was based on data from three studies. The first compared Ga 68 dotatate images of NETs to images obtained with an approved drug, and then confirmed with computed tomography or magnetic resonance imaging. The second study evaluated Ga 68 dotatate images using histopathology or clinical follow up as reference standards. And the third evaluated patients with NET recurrence using Ga 68 dotatate images. “The results of all three studies confirmed the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors,” the agency says.