From the Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals (National Medical Products Administration), Department of Nuclear Medicine (X.G., N.Z., J.L., J.D., T.L., H.Z., Z.Y.), and Department of Breast Oncology (G.S.), Peking University Cancer Hospital & Institute, Beijing 100142, China.
Radiology. 2024 Jun;311(3):e232209. doi: 10.1148/radiol.232209.
Background Human epidermal growth factor receptor 2 (HER2) affibody-based tracers could be an alternative to nonspecific radiotracers for noninvasive detection of HER2 expression in breast cancer lesions at PET/CT. Purpose To compare an affibody-based tracer, AlF-NOTA-HER2-BCH, and fluorine 18 (F) fluorodeoxyglucose (FDG) for detecting HER2-positive breast cancer lesions on PET/CT images. Materials and Methods In this prospective study conducted from June 2020 to July 2023, participants with HER2-positive breast cancer underwent both AlF-NOTA-HER2-BCH and F-FDG PET/CT. HER2 positivity was confirmed with pathologic assessment (immunohistochemistry test results of 3+, or 2+ followed by fluorescence in situ hybridization, indicated HER2 amplification). Two independent readers visually assessed the uptake of tracers on images. Lesion uptake was quantified using the maximum standardized uptake value (SUV) and target to background ratio (TBR) and compared using a general linear mixed model. Results A total of 42 participants (mean age, 56.3 years ± 10.1 [SD]; 41 female) with HER2-positive breast cancer were included; 42 (100%) had tumors that were detected with AlF-NOTA-HER2-BCH PET/CT and 40 (95.2%) had tumors detected with F-FDG PET/CT. Primary tumors in two of 21 participants, lymph node metastases in four of 21 participants, bone metastases in four of 15 participants, and liver metastases in three of nine participants were visualized only with AlF-NOTA-HER2-BCH. Lung metastasis in one of nine participants was visualized only with F-FDG. AlF-NOTA-HER2-BCH enabled depiction of more suspected HER2-positive primary tumors (26 vs 21) and lymph node (170 vs 130), bone (92 vs 66), and liver (55 vs 27) metastases than F-FDG. The SUV and TBR values of primary tumors and lymph node, bone, and liver metastases were all higher on AlF-NOTA-HER2-BCH images than on F-FDG images (median SUV range, 10.4-13.5 vs 3.4-6.2; value range, <.001 to .02; median TBR range, 2.7-17.6 vs 1.2-7.8; value range, <.001 to .001). No evidence of differences in the SUV and TBR for chest wall or lung metastases was observed between AlF-NOTA-HER2-BCH and F-FDG ( value range, .06 to .53). Conclusion PET/CT with the affibody-based tracer AlF-NOTA-HER2-BCH enabled detection of more primary lesions and lymph node, bone, and liver metastases than PET/CT using F-FDG. ClinicalTrials.gov Identifier: NCT04547309 © RSNA, 2024 See also the editorial by Ulaner in this issue.
背景 人表皮生长因子受体 2（HER2）亲和体示踪剂可作为非特异性放射性示踪剂的替代物，用于在正电子发射断层扫描/计算机断层扫描（PET/CT）中无创检测乳腺癌病变中的 HER2 表达。目的 比较基于亲和体的示踪剂 AlF-NOTA-HER2-BCH 与氟 18（F）氟脱氧葡萄糖（FDG）在 PET/CT 图像上检测 HER2 阳性乳腺癌病变的性能。材料与方法 本前瞻性研究于 2020 年 6 月至 2023 年 7 月进行，HER2 阳性乳腺癌患者同时接受 AlF-NOTA-HER2-BCH 和 F-FDG PET/CT 检查。HER2 阳性通过病理评估（免疫组织化学检测结果为 3+，或 2+ 伴荧光原位杂交，提示 HER2 扩增）确认。两位独立的读者在图像上对示踪剂摄取情况进行了视觉评估。使用最大标准化摄取值（SUV）和靶标与背景比（TBR）对病变摄取进行定量，并使用一般线性混合模型进行比较。结果 共纳入 42 例（平均年龄，56.3 岁±10.1[标准差]；41 例女性）HER2 阳性乳腺癌患者；42 例（100%）患者的肿瘤在 AlF-NOTA-HER2-BCH PET/CT 上可见，40 例（95.2%）患者的肿瘤在 F-FDG PET/CT 上可见。21 例患者中有 2 例原发性肿瘤，21 例患者中有 4 例淋巴结转移，15 例患者中有 4 例骨转移，9 例患者中有 3 例肝转移，仅用 AlF-NOTA-HER2-BCH 可见。9 例患者中有 1 例肺转移仅用 F-FDG 可见。AlF-NOTA-HER2-BCH 能够更好地显示疑似 HER2 阳性的原发性肿瘤（26 个 vs 21 个）和淋巴结（170 个 vs 130 个）、骨（92 个 vs 66 个）和肝（55 个 vs 27 个）转移。原发性肿瘤和淋巴结、骨和肝转移的 SUV 和 TBR 值在 AlF-NOTA-HER2-BCH 图像上均高于 F-FDG 图像（SUV 值范围，10.4-13.5 比 3.4-6.2； 值范围，<.001 至.02；TBR 值范围，2.7-17.6 比 1.2-7.8； 值范围，<.001 至.001）。在 AlF-NOTA-HER2-BCH 和 F-FDG 中，胸壁或肺转移的 SUV 和 TBR 差异无统计学意义（ 值范围，.06 至.53）。结论 与 F-FDG 相比，基于亲和体的示踪剂 AlF-NOTA-HER2-BCH 的 PET/CT 能够更好地检测原发性病变和淋巴结、骨和肝转移。临床试验注册编号：NCT04547309 参见本期的社论。
