Michael M. Graham, Xiaomei Gu, Timothy Ginader, Patrick Breheny, John J. Sunderland

(68)Ga-DOTATOC, a somatostatin receptor targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be quite sensitive and effective for clinical management decision-making. This meta-analysis summarizes the efficacy of (68)Ga-DOTATOC for several distinct indications and is intended to support approval of this agent by the U.S. Food and Drug Administration. Methods: The major electronic medical databases were searched for relevant papers over the period from January 2001 until November 2015. Papers were selected for review in 3 categories: clinical trials that reported sensitivity and specificity, comparison studies with (111)In-octreotide, and change of management studies. All the eligible papers underwent Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment, which was useful in the final selection of papers for review. Results: The initial search yielded 468 papers. After detailed evaluation, 17 papers were finally selected. Five types of studies emerged: workup of patients with symptoms and biomarker findings suggestive of NET, but with negative conventional imaging (3 papers, yield was only 13%); sensitivity (12 papers, sensitivity 92%,) and specificity (7 papers, specificity 82%); identification of site of unknown primary in patients with metastatic NET (4 papers, yield was 44%); impact on subsequent NET patient management (4 papers - change in management in 51%); and comparison with (111)In-octreotide (2 papers, sensitivity of DOTATOC on a per lesion basis was 100%,for (111)In-octreotide was 78.2%; specificity was not available). Safety was not explicitly addressed in any study, but there were no reports of adverse events. Conclusion:(68)Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging, restaging, and to assist in treatment decision making for patients with NET. It is also effective in locating the site of an unknown primary in NET patients that present with metastatic NET, but no known primary tumor. It also appears to be more accurate than (111)In-octreotide. Although (68)Ga-DOTATOC would seem to be useful in evaluating patients with suggestive symptoms and biomarker findings, it does not perform well in this setting and has low yield. Overall, it appears to be an excellent imaging agent to assess patients with known NET and frequently leads to a change in management.