68Ga-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 metaanalysis summarizes the efficacy of 68Ga-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 to November 2015. Papers were selected for review in 3 categories: clinical trials that reported sensitivity and specificity, comparison studies with 111In-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 111In-octreotide (2 papers, sensitivity of DOTATOC on a per-lesion basis was 100%, for 111In-octreotide it was 78.2%; specificity was not available). Safety was not explicitly addressed in any study, but there were no reports of adverse events. Conclusion:68Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging and restaging and for assisting in treatment decision making for patients with NET. It is also effective in locating the site of an unknown primary in NET patients who present with metastatic NET, but no known primary tumor. It also appears to be more accurate than 111In-octreotide. Although 68Ga-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.

中文翻译：

---

神经内分泌肿瘤的 68Ga-DOTATOC 成像：系统回顾和荟萃分析。

68Ga-DOTATOC 是一种生长抑素受体靶向配体，过去十年在欧洲临床上用于神经内分泌肿瘤 (NET) 成像。它对于临床管理决策来说似乎相当敏感和有效。该荟萃分析总结了 68Ga-DOTATOC 对几种不同适应症的功效，旨在支持美国食品和药物管理局批准该药物。方法：检索2001年1月至2015年11月期间主要电子医学数据库中的相关论文。论文分为3类进行审查：报告敏感性和特异性的临床试验、与111In-奥曲肽的比较研究以及管理变更学习。所有符合条件的论文都经过了诊断准确性研究质量评估（QUADAS）评估，这对于最终选择审查论文很有用。结果：初步检索共找到 468 篇论文。经过详细评审，最终评选出17篇论文。出现了五种类型的研究：对有症状和生物标志物结果提示 NET 但常规影像学阴性的患者进行检查（3 篇论文，产率仅为 13%）；敏感性（12 篇论文；敏感性，92%）和特异性（7 篇论文；特异性，82%）；转移性 NET 患者原发部位不明的识别（4 篇论文，产率 44%）；对后续 NET 患者管理的影响（4 篇论文，51% 的管理发生变化）；以及与 111In-奥曲肽的比较（2 篇论文，DOTATOC 基于每个病变的敏感性为 100%，111In-奥曲肽为 78.2%；特异性不可用）。任何研究都没有明确讨论安全性，但没有不良事件的报告。结论：68Ga-DOTATOC对于评估疾病的存在和程度、分期和再分期以及协助NET患者的治疗决策是有用的。对于患有转移性 NET 但没有已知原发肿瘤的 NET 患者，它还可有效定位未知原发肿瘤的部位。它似乎也比 111In-奥曲肽更准确。尽管 68Ga-DOTATOC 似乎可用于评估具有提示性症状和生物标志物结果的患者，但它在这种情况下表现不佳且产量较低。总体而言，它似乎是一种出色的显像剂，可用于评估已知 NET 的患者，并经常导致治疗方法的改变。