Diagnostic efficacy and safety of 99mTc-Labeled monoclonal antibody ior c5 in patients with colorectal and anal carcinomas: Final report clinical trial phase I/II
Diagnostic efficacy and safety of 99mTc-Labeled monoclonal antibody ior c5 in patients with colorectal and anal carcinomas: Final report clinical trial phase I/II
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99mTc 标记的单克隆抗体 ior c5 对结直肠癌和肛门癌患者的诊断功效和安全性：I/II 期临床试验最终报告
作者：
M. Ramos;A. Perera Pintado;N. R. Mesa;J. Oliva;N. Iznaga;L. T. Aroche;G. Pimentel;J. González;M. Cordero;Obaya T. Rodríguez;R. T. Crombet;R. Pérez
c5单克隆抗体（mAb）是一种IgG 1，其识别在结肠癌和卵巢癌细胞表面过表达的糖蛋白肿瘤特异性抗原IOR C2。本工作的目的是评价99 mTc标记的mAb ior c5对结直肠肿瘤及其转移和复发的诊断效力。研究方法：86名平均年龄57 ± 13岁的结直肠癌或肛门癌患者参与了一项I/II期多中心开放临床试验，以评估99 mTc-mAb或c5放射免疫闪烁成像（RIS）检测这些肿瘤的能力。74例患者接受1 mg 1480-1850 MBq标记的c5，以通过静脉（i.v）推注确定鼠mAb的诊断有效性和安全性（组1）。为了评价这种放射性标记分子的药代动力学、生物分布和剂量测定，12名患者接受了3 mg标记的ior c5。在注射后2、4和18-24小时，使用矩阵大小128 x128和每次视图500 K计数采集病变部位和疑似转移灶的平面前部和后部图像。在注射后5小时使用360°圆形轨道扫描SPECT，具有64个图像。在给药后2、4、8和12周测量血清中的HAMA反应。结果：标记效率为（97.8 ± 0.6）%。未观察到不良反应或副作用。免疫闪烁显像的敏感性、特异性、准确性、阳性预测值和阴性预测值分别为95.80%、100%、96.51%、100.0%和82.35%。86例中有37例（43.02%）发现不明转移灶。结论：99 mTc标记的c_5单克隆抗体免疫闪烁显像对结直肠肿瘤的诊断、转移和复发的随访有重要价值。
Monoclonal antibody (mAb) ior c5 is an IgG1, which recognizes a glycoprotein tumor specific antigen IOR C2 over expressed in the surface of colon and ovarian cancer cells. The aim of the present work was to evaluate the diagnostic efficacy of the 99mTc-labeled mAb ior c5 for the detection of colorectal tumors, its metastases and recurrences. Methods: Eighty six patients with colorectal or anal cancer, mean age 57 +/- 13 yrs, were involved in a phase I/II multicentric, open clinical trial to assess the ability of Radioimmunoscintigraphy (RIS) with 99mTc- mAb ior c5 to detect those tumors. 74 patients received 1 mg of c5 labeled with 1480-1850 MBq to determinate diagnosis efficacy and safety of murine mAb by intravenously (i.v) bolus injection (group 1). In order to evaluate pharmacokinetic, bio distribution and dosimetry of this radiolabel molecule, 12 patients received 3 mg of labeled ior c5. Planar anterior and posterior images of the lesion sites and suspected metastases were acquired at 2, 4 and 18-24 hours after injection using a matrix size 128 x128 and 500 Kcounts per view. SPECT were scanned at 5 hr post-injection, using a 360° circular orbit with 64 images. HAMA response was measured in serum at 2, 4, 8 and 12 week post-administration. Results: Labeling efficiency was (97.8 ± 0.6) %. No adverse reactions or side effects were observed. Overall sensitivity, specificity, accuracy, positive and negative predictive values of the immunoscintigraphy were 95.80%, 100%, 96.51%, 100.0% and 82.35%, respectively. Unknown metastases were detected in 37 of 86 cases (43.02%). No HAMA response was found. Conclusions: Immunoscintigraphy with 99mTc -labeled mAb ior c5 could be a useful procedure for the diagnosis and follow-up of the patients with colorectal tumors, its metastasis and recurrences.