Abdel-Nabi H, Doerr R J, Evans N H, Farrell E E, Chan H W, Balu D, Gona J, Schweighardt S
Department of Nuclear Medicine, State University of New York at Buffalo.
Nucl Med Commun. 1994 Feb;15(2):81-93. doi: 10.1097/00006231-199402000-00004.
The aims of this prospective, nonrandomized phase I/II study were to evaluate (1) the safety and (2) the detection rate of tissue culture-derived, 111In-labelled anti-CEA monoclonal antibody IVP ZCE 025 in patients with primary, metastatic and occult colorectal carcinomas. 111In-IVP ZCE 025 imaging correctly identified 31 of 37 primary colorectal carcinomas, 10 of 19 hot liver metastases, 11 of 16 distant metastases and seven of seven local tumour recurrences. Previously unsuspected tumours were detected by IVP ZCE 025 imaging in 11 of 34 patients. The scans were also true negative in four patients. The overall performance characteristics of IVP ZCE 025 at monoclonal antibody doses of 1.0-5.0 mg were comparable to those obtained with 40.0 mg ascites-produced ZCE 025. No clinical or biochemical adverse reactions were encountered in the 61 patients entered into this study.
这项前瞻性、非随机的I/II期研究的目的是评估：（1）组织培养来源的、111铟标记的抗癌胚抗原单克隆抗体IVP ZCE 025在原发性、转移性和隐匿性结直肠癌患者中的安全性；（2）其检测率。111铟-IVP ZCE 025成像正确识别出37例原发性结直肠癌中的31例、19例肝脏热转移灶中的10例、16例远处转移灶中的11例以及7例局部肿瘤复发中的7例。IVP ZCE 025成像在34例患者中的11例中检测到了先前未被怀疑的肿瘤。4例患者的扫描结果也为真阴性。在单克隆抗体剂量为1.0 - 5.0 mg时，IVP ZCE 025的总体性能特征与使用40.0 mg腹水产生的ZCE 025所获得的特征相当。参与本研究的61例患者均未出现临床或生化不良反应。
