Jin Xiaona, Zhang Yuwei, Cao Xi, Wang Peipei, Ren Chao, Cai Jiong, Wang Xuefei, Jing Hongli, Sun Qiang, Li Fang
From the Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing, China.
Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Clin Nucl Med. 2025 Jan 1;50(1):25-30. doi: 10.1097/RLU.0000000000005535.
Accuracy in in vivo assessment of human epidermal growth factor receptor type 2 (HER2) status is crucial for predicting the response to HER2-targeted therapies in breast cancer. This study assessed the safety, feasibility, and diagnostic accuracy of 99mTc-ABH2, a reengineered affibody molecule with radionuclide labeling, for HER2 expression in breast cancer using SPECT/CT imaging, compared with 18F-FDG PET/CT.
Thirty-six patients suspected of primary breast cancer were enrolled in this prospective, single-center study from March to July in 2023. Each participant underwent SPECT/CT imaging with 99mTc-ABH2 SPECT/CT and 18F-FDG PET/CT. The imaging results were validated against immunohistochemistry and fluorescence in situ hybridization, employing visual scores and quantitative values for analysis.
Optimal imaging contrast was observed around 2 hours postinjection of 99mTc-ABH2. Among the evaluated 27 patients with immunohistochemistry and fluorescence in situ hybridization findings, the 99mTc-ABH2 SPECT/CT visual evaluation displayed a sensitivity of 71.4%, specificity of 72.2%, and accuracy of 71.9%. Using an SUVmax cutoff of 2.32, the sensitivity, specificity, and accuracy for detecting HER2 status were 92.86%, 72.22%, and 81.25%, respectively. Notably, 99mTc-ABH2 precisely identified all immunohistochemistry (3+) tumors and showed increased uptake in bone and lymph node metastases. Meanwhile, 18F-FDG PET/CT showed no significant difference in uptake between HER2 (2+/3+) and HER2 (0/1+) tumors (P = 0.81).
This study validated 99mTc-ABH2 SPECT/CT as a promising diagnostic tool for precise HER2 assessment. The robust sensitivity for immunohistochemistry (3+) tumors and the visualization of metastases highlight its diagnostic significance, potentially impacting patient outcomes positively.
准确评估人表皮生长因子受体2（HER2）的体内状态对于预测乳腺癌患者对HER2靶向治疗的反应至关重要。本研究使用SPECT/CT成像评估了经放射性核素标记的重组亲和体分子99mTc-ABH2用于乳腺癌HER2表达的安全性、可行性及诊断准确性，并与18F-FDG PET/CT进行比较。
2023年3月至7月，36例疑似原发性乳腺癌患者纳入了这项前瞻性单中心研究。每位参与者均接受了99mTc-ABH2 SPECT/CT和18F-FDG PET/CT检查。成像结果通过免疫组织化学和荧光原位杂交进行验证，采用视觉评分和定量值进行分析。
注射99mTc-ABH2后约2小时观察到最佳成像对比度。在评估的27例有免疫组织化学和荧光原位杂交结果的患者中，99mTc-ABH2 SPECT/CT视觉评估的敏感性为71.4%，特异性为72.2%，准确性为71.9%。使用SUVmax临界值2.32时，检测HER2状态的敏感性、特异性和准确性分别为92.86%、72.22%和81.25%。值得注意的是，99mTc-ABH2准确识别了所有免疫组织化学（3+）肿瘤，并显示出在骨和淋巴结转移灶中有摄取增加。同时，18F-FDG PET/CT显示HER2（2+/3+）和HER2（0/1+）肿瘤之间的摄取无显著差异（P = 0.81）。
本研究验证了99mTc-ABH2 SPECT/CT作为一种有前景的精确评估HER2的诊断工具。对免疫组织化学（3+）肿瘤的高敏感性以及转移灶的可视化突出了其诊断意义，可能对患者的治疗结果产生积极影响。
