Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.
Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.
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DOI：
10.2967/jnumed.115.163865
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发表时间：
2016-05
期刊：
影响因子：
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通讯作者：
Walker RC
中科院分区：
文献类型：
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作者：
Deppen SA;Liu E;Blume JD;Clanton J;Shi C;Jones-Jackson LB;Lakhani V;Baum RP;Berlin J;Smith GT;Graham M;Sandler MP;Delbeke D;Walker RC
我们的目的是评价68 Ga-DOTATATE PET/CT与111 In-pentetreotide成像在肺和胃肠胰腺神经内分泌肿瘤诊断、分期和再分期中的安全性和有效性。对97例连续入选的已知或疑似肺或胃肠胰腺神经内分泌肿瘤患者中的78例进行了68 Ga-DOTATATE PET/CT和111 In-喷替曲肽扫描。通过比较68 Ga-DOTATATE注射前后的生命体征、血清化学值或采集相关的医学并发症来测量安全性和毒性。当68 Ga-DOTATATE PET/CT结果被添加到所有先前的成像（包括111 In-喷替曲肽）中时，治疗计划的变化确定了附加值。在盲法和非盲法解读者之间测量68 Ga-DOTATATE PET/CT扫描解读的观察者间重现性。68 Ga-DOTATATE PET/CT和111 In-喷替曲肽对治疗的影响有显著性差异（P < 0.001）。68 Ga-DOTATATE PET/CT联合CT或肝脏MRI改变了78例患者中的28例（36%）的治疗。观察者间一致性之间的盲和非盲口译员是高的。无受试者发生需要治疗的试验相关事件。轻度一过性事件包括1例心动过速、1例丙氨酸转氨酶升高和2例高血糖。未发生具有临床意义的心律失常。68 Ga-DOTATATE PET/CT正确识别了3例被111 In-喷替曲肽错误分类的肽受体放疗患者。在所有78例患者中，68 Ga-DOTATATE PET/CT与111 In-喷替曲肽成像等同或上级。未观察到需要治疗的不良事件。68 Ga-DOTATATE PET/CT改变了36%的参与者的治疗。鉴于与111 In-喷替曲肽相比，68 Ga-DOTATATE成像没有显著毒性，辐射暴露较低，准确性更高，因此应使用68 Ga-DOTATATE成像代替111 In-喷替曲肽成像。
Our purpose was to evaluate safety and efficacy of 68Ga-DOTATATE PET/CT compared with 111In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors. 68Ga-DOTATATE PET/CT and 111In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after 68Ga-DOTATATE injection. Added value was determined by changes in treatment plan when 68Ga-DOTATATE PET/CT results were added to all prior imaging, including 111In-pentetreotide. Interobserver reproducibility of 68Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters. 68Ga-DOTATATE PET/CT and 111In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). 68Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. 68Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by 111In-pentetreotide. 68Ga-DOTATATE PET/CT was equivalent or superior to 111In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. 68Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with 111In-pentetreotide, 68Ga-DOTATATE imaging should be used instead of 111In-pentetreotide imaging where available.