Abstract：
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, Al18F-NOTA-HER2-BCH, and fluorine 18 (18F) 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 Al18F-NOTA-HER2-BCH and 18F-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 (SUVmax) 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 Al18F-NOTA-HER2-BCH PET/CT and 40 (95.2%) had tumors detected with 18F-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 Al18F-NOTA-HER2-BCH. Lung metastasis in one of nine participants was visualized only with 18F-FDG. Al18F-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 18F-FDG. The SUVmax and TBR values of primary tumors and lymph node, bone, and liver metastases were all higher on Al18F-NOTA-HER2-BCH images than on 18F-FDG images (median SUVmax range, 10.4-13.5 vs 3.4-6.2; P value range, <.001 to .02; median TBR range, 2.7-17.6 vs 1.2-7.8; P value range, <.001 to .001). No evidence of differences in the SUVmax and TBR for chest wall or lung metastases was observed between Al18F-NOTA-HER2-BCH and 18F-FDG (P value range, .06 to .53). Conclusion PET/CT with the affibody-based tracer Al18F-NOTA-HER2-BCH enabled detection of more primary lesions and lymph node, bone, and liver metastases than PET/CT using 18F-FDG. ClinicalTrials.gov Identifier: NCT04547309 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Ulaner in this issue.
摘要：
背景人类表皮生长因子受体2（HER2）亲和体示踪剂可以替代非特异性放射性示踪剂，用于在PET/CT上无创检测乳腺癌病变中HER2的表达。目的比较基于亲和体的示踪剂，Al18F-NOTA-HER2-BCH,和氟18（18F）氟脱氧葡萄糖（FDG）用于在PET/CT图像上检测HER2阳性乳腺癌病变。材料和方法在2020年6月至2023年7月进行的这项前瞻性研究中，患有HER2阳性乳腺癌的参与者接受了Al18F-NOTA-HER2-BCH和18F-FDGPET/CT。病理评估证实HER2阳性（免疫组织化学检测结果为3+，或2+，然后进行荧光原位杂交，指示HER2扩增)。两个独立的阅读器在视觉上评估了图像上示踪剂的摄取。使用最大标准化摄取值(SUVmax)和目标与背景比(TBR)定量病变摄取,并使用一般线性混合模型进行比较。结果共有42名参与者(平均年龄，包括56.3岁±10.1[SD];41名女性）HER2阳性乳腺癌；42名（100％）患有Al18F-NOTA-HER2-BCHPET/CT检测到的肿瘤，40名（95.2％）患有18F-FDGPET/CT检测到的肿瘤。21名参与者中有2名原发性肿瘤，21名参与者中有4名淋巴结转移，15名参与者中有4名骨转移，仅使用Al18F-NOTA-HER2-BCH观察9名参与者中的3名肝转移。仅使用18F-FDG观察了9名参与者之一的肺转移。Al18F-NOTA-HER2-BCH能够描绘更多可疑的HER2阳性原发肿瘤（26vs21）和淋巴结（170vs130），骨（92vs66），和肝转移（55vs27）比18F-FDG。原发肿瘤和淋巴结的SUVmax和TBR值，骨头,Al18F-NOTA-HER2-BCH图像上的肝转移均高于18F-FDG图像（中位SUVmax范围，10.4-13.5与3.4-6.2；P值范围，<.001至.02；TBR范围中位数，2.7-17.6vs1.2-7.8；P值范围，<.001至.001）。在Al18F-NOTA-HER2-BCH和18F-FDG之间，没有观察到胸壁或肺转移的SUVmax和TBR差异的证据（P值范围，.06至.53）。结论PET/CT结合基于蛋白质的示踪剂Al18F-NOTA-HER2-BCH可以检测更多的原发性病变和淋巴结。骨头,和肝转移比使用18F-FDG的PET/CT。ClinicalTrials.gov标识符：NCT04547309©RSNA，2024补充材料可用于本文。另请参阅本期Ulaner的社论。
