Dresel S, Kirsch C M, Tatsch K, Zachoval R, Hahn K, Goldenberg D M
Department of Nuclear Medicine, University of Munich, Klinikum Grosshadern, Germany.
J Clin Oncol. 1997 Jul;15(7):2683-90. doi: 10.1200/JCO.1997.15.7.2683.
The aim of this phase II study was to assess the clinical utility and safety of AFP-Scan (Immunomedics, Inc, Morris Plains, NJ), a technetium-99m (99mTc)-labeled anti-alpha-fetoprotein (AFP) Fab' imaging kit, in the evaluation of hepatocellular carcinoma (HCC), in comparison to computed tomography (CT).
Twenty-five consecutive patients with a history of HCC were examined by planar and single-photon emission computed tomography (SPECT) imaging at 6 and 24 hours after intravenous (I.V.) injection of 1 mg AFP-Scan labeled with 925 MBq 99mTc.
In 20 patients, there was a specific binding of the Fab' antibody to the tumor, whereas in four patients who presented with elevated serum AFP levels, no specific targeting was found and no malignant lesions were evident by CT or biopsy. One patient was diagnosed as false-negative by AFP-Scan. In five of six patients with normal serum AFP levels, focal uptake was demonstrated. In one case, metastatic disease in the lower abdomen was found. In all patients, diagnostically relevant information was provided by the 24-hour antibody images, especially with SPECT. Comparing AFP-Scan versus CT, the former showed a higher sensitivity (95% v 63%) and specificity (67% v 17%), with an overall accuracy of 88% versus 52% for AFP-Scan versus CT, even in patients with normal serum AFP titers. No adverse reactions or human antimouse antibody (HAMA) elevations were found in any of the patients.
AFP-Scan appears to be a promising new antibody imaging kit for the disclosure of sites of HCC and should aid in the management of these patients by revealing primary, recurrent, and metastatic disease with a single imaging modality.
本II期研究旨在评估锝-99m（99mTc）标记的抗甲胎蛋白（AFP）Fab'成像试剂盒AFP-Scan（Immunomedics公司，新泽西州莫里斯平原）在肝细胞癌（HCC）评估中的临床实用性和安全性，并与计算机断层扫描（CT）进行比较。
连续25例有HCC病史的患者在静脉注射1 mg用925 MBq 99mTc标记的AFP-Scan后6小时和24小时接受平面和单光子发射计算机断层扫描（SPECT）成像检查。
20例患者中，Fab'抗体与肿瘤有特异性结合，而4例血清AFP水平升高的患者未发现特异性靶向，CT或活检也未发现恶性病变。1例患者被AFP-Scan诊断为假阴性。6例血清AFP水平正常的患者中有5例显示局灶性摄取。1例患者发现下腹部有转移病灶。在所有患者中，24小时抗体图像，尤其是SPECT图像，提供了诊断相关信息。比较AFP-Scan与CT，前者显示出更高的敏感性（95%对63%）和特异性（67%对17%），AFP-Scan与CT的总体准确率分别为88%和52%，即使在血清AFP滴度正常的患者中也是如此。所有患者均未发现不良反应或人抗鼠抗体（HAMA）升高。
AFP-Scan似乎是一种有前景的新型抗体成像试剂盒，可用于揭示HCC病灶，并且通过单一成像方式揭示原发性、复发性和转移性疾病，应有助于这些患者的管理。
