Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses:: a phase I trial
Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses:: a phase I trial
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DOI：
10.1016/s1470-2045(07)70044-x
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发表时间：
2007-04-01
期刊：
影响因子：
51.1
通讯作者：
Russo, Paul
中科院分区：
文献类型：
--
作者：
Divgi, Chaitanya R.;Pandit-Taskar, Neeta;Russo, Paul
背景：术前对肿瘤类型的识别对肾癌治疗的选择有重要意义。抗体cG250与碳酸氢酶-IX反应，该酶在高细胞肾癌中过度表达。我们旨在评估碘-124标记抗体嵌合G250(I-124-cG250)PET对最常见和最具侵袭性的肾脏肿瘤-透明细胞肾癌的预测价值。方法在这项开放标记的初步研究中，26例肾肿块患者在20分钟内接受了185MBq/10 mg I-124-cG250的单次静脉滴注。手术安排在I-124-cG250输注后1周进行。所有患者均计划在手术前3小时内进行腹部(包括肾脏)的PET和CT扫描。获得的图像被分级为阳性(定义为肿瘤与健康肾脏的比率>；3：1)或抗体摄取阴性，外科医生在手术前被告知扫描结果。手术后，切除的肿瘤在组织病理学上被归类为透明细胞肾癌或其他。这项试验在国家癌症研究所网站http://clinicaltrials.gov/ct/SHOW/NCT00199888的临床试验网站上注册。结果发现，一名患者接受了灭活抗体，并被排除在分析之外。16个透明细胞癌中有15个通过抗体PET准确识别，所有9个非透明细胞肾肿块示踪剂均为阴性。I-125-cG250 PET诊断肾透明细胞癌的敏感性为94%(95%CI 70-100%)，阴性预测值为90%(55-100%)，特异性和阳性预测值均为100%(66-100%和78-100%)。通过(124)-cG250 PET对肾肿块患者进行分层可以识别侵袭性肿瘤并帮助决定治疗。
Background Preoperative identification of tumour type could have important implications for the choice of treatment for renal cancers. Antibody cG250 reacts against carbonic anhydrase-IX, which is over-expressed in dear-cell renal carcinomas. We aimed to assess whether iodine-124-labelled antibody chimeric G250 (I-124-cG250) PET predicts clear-cell renal carcinoma, the most common and aggressive renal tumour.Methods 26 patients with renal masses who were scheduled to undergo surgical resection by laparotomy received a single intravenous infusion of 185 MBq/10 mg of I-124-cG250 over 20 min in this open-label pilot study. Surgery was scheduled 1 week after I-124-cG250 infusion. PET and CT scanning of the abdomen, including the kidneys, within 3 h before surgery was planned for all patients. The obtained images were graded as positive (defined as a tumour-to-healthy-kidney ratio > 3 to 1) or negative for antibody uptake, and the surgeon was informed of the scan results before surgery. After surgery, resected tumours were histopathologically classified as clear-cell renal carcinoma or otherwise. The trial is registered on the clinical trials site of the National Cancer Institute website http://clinicaltrials.gov/ct/ show/NCT00199888.Findings One patient received inactive antibody and was excluded from analysis. 15 of 16 clear-cell carcinomas were identified accurately by antibody PET, and all nine non-clear-cell renal masses were negative for the tracer. The sensitivity of I-125-cG250 PET for dear-cell kidney carcinoma in this trial was 94% (95% CI 70-100%); the negative predictive value was 90% (55-100%), and specificity and positive predictive accuracy were both 100% (66-100% and 78-100%, respectively).Interpretation PET with (124)-cG250 can identify accurately clear-cell renal carcinoma; a negative scan is highly predictive of a less aggressive phenotype. Stratification of patients with renal masses by (124)-cG250 PET can identify aggressive tumours and help decide treatment.