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68Ga-DOTATATE PET/CT在神经内分泌肿瘤诊断、分期及治疗管理中的安全性与有效性

Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.

作者信息

Deppen Stephen A, Liu Eric, Blume Jeffrey D, Clanton Jeffrey, Shi Chanjuan, Jones-Jackson Laurie B, Lakhani Vipul, Baum Richard P, Berlin Jordan, Smith Gary T, Graham Michael, Sandler Martin P, Delbeke Dominique, Walker Ronald C

机构信息

Veterans Affairs Hospital, Tennessee Valley VA Healthcare System, Nashville, Tennessee Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.

Rocky Mountain Cancer Centers, Denver, Colorado.

出版信息

J Nucl Med. 2016 May;57(5):708-14. doi: 10.2967/jnumed.115.163865. Epub 2016 Jan 14.

Abstract

UNLABELLED

Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors.

METHODS

(68)Ga-DOTATATE PET/CT and (111)In-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 (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters.

RESULTS

(68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). (68)Ga-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. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide.

CONCLUSION

(68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.

摘要

未标注

我们的目的是评估与(111)铟-喷曲肽成像相比,(68)镓-奥曲肽PET/CT在肺和胃肠胰神经内分泌肿瘤的诊断、分期及再分期中的安全性和有效性。

方法

对97例连续入组的已知或疑似肺或胃肠胰神经内分泌肿瘤患者中的78例进行了(68)镓-奥曲肽PET/CT和(111)铟-喷曲肽扫描。通过比较(68)镓-奥曲肽注射前后的生命体征、血清化学值或与采集相关的医学并发症来测量安全性和毒性。当将(68)镓-奥曲肽PET/CT结果添加到所有先前的影像学检查(包括(111)铟-喷曲肽)中时,根据治疗计划的变化来确定附加值。在盲法和非盲法解释者之间测量(68)镓-奥曲肽PET/CT扫描解释的观察者间再现性。

结果

(68)镓-奥曲肽PET/CT和(111)铟-喷曲肽扫描对治疗的影响有显著差异(P<0.001)。(68)镓-奥曲肽PET/CT联合CT或肝脏MRI使78例患者中的28例(36%)的治疗发生了改变。盲法和非盲法解释者之间的观察者间一致性较高。没有参与者发生需要治疗的试验相关事件。轻度、短暂事件包括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)镓-奥曲肽PET/CT正确识别出3例被(111)铟-喷曲肽错误分类的适合肽受体放疗的患者。

结论

在所有78例患者中,(68)镓-奥曲肽PET/CT等同于或优于(111)铟-喷曲肽成像。未观察到需要治疗的不良事件。(68)镓-奥曲肽PET/CT使36%的参与者的治疗发生了改变。鉴于与(111)铟-喷曲肽相比,其毒性不显著、辐射暴露更低且准确性更高,在可获得(68)镓-奥曲肽成像的情况下,应使用(68)镓-奥曲肽成像而非(111)铟-喷曲肽成像。

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