<br>使用 99mTc-NM-02 纳米抗体检测乳腺癌患者 HER2 表达：一项非随机、非盲临床试验,Breast Cancer Research

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使用 99mTc-NM-02 纳米抗体检测乳腺癌患者 HER2 表达：一项非随机、非盲临床试验
Breast Cancer Research ( IF 6.1 ) Pub Date : 2024-03-08 , DOI: 10.1186/s13058-024-01803-y
Lingzhou Zhao ₁ , Yan Xing ₁ , Changcun Liu ₁ , Shaofei Ma ₂ , Wenhua Huang ₃ , Zhen Cheng _{4,

5} , Jinhua Zhao ₁

Affiliation

99mTc 放射性标记纳米抗体 NM-02 (99mTc-NM-02) 是一种新型单光子发射计算机断层扫描 (SPECT) 探针，对人表皮生长因子受体 2 (HER2) 具有高亲和力和特异性。在这项研究中，进行了一项临床影像试验，以调查乳腺癌患者 99mTc-NM-02 摄取与 HER2 表达之间的关系。招募了 30 名经病理证实的乳腺癌患者，并使用 99mTc-NM-02 SPECT/计算机断层扫描 (CT) 和 18F-氟脱氧葡萄糖 (18F-FDG) 正电子发射断层扫描 (PET)/CT 进行成像。根据入组前的治疗情况，将患者分为两组，初诊组（n = 24）和治疗组（n = 6）。测定病灶内18F-FDG最大标准摄取值(SUVmax)、SUVmax和99mTc-NM-02平均SUV(SUVmean),分析与HER2表达的关系。在 30 名乳腺癌患者中未观察到 18F-FDG 摄取与 HER2 表达之间存在有意义的关系。在初诊组中99mTc-NM-02摄取与HER2表达呈正相关，但在治疗组中未观察到相关性。与新诊断组相比，接受有效 HER2 靶向治疗的患者 HER2 阳性病变中 99mTc-NM-02 的摄取较低。 99mTc-NM-02 SPECT/CT 以与 18F-FDG PET/CT 不同的成像模式检测乳腺癌的脑和骨转移。 99mTc-NM-02 在发炎组织中没有表现出非特异性摄取，并且在 30 名乳腺癌患者中的 9 名中通过 SPECT/CT 成像显示了肿瘤内和肿瘤间 HER2 异质性。 99mTc-NM-02 SPECT/CT 具有可视化未经治疗患者全身 HER2 过度表达的潜力，使其成为乳腺癌患者 HER2 评估的一种有前景的方法。 NCT04674722，注册日期：2020年12月19日。

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Detection of HER2 expression using 99mTc-NM-02 nanobody in patients with breast cancer: a non-randomized, non-blinded clinical trial

99mTc radiolabeled nanobody NM-02 (99mTc-NM-02) is a novel single photon emission computed tomography (SPECT) probe with a high affinity and specificity for human epidermal growth factor receptor 2 (HER2). In this study, a clinical imaging trial was conducted to investigate the relationship between 99mTc-NM-02 uptake and HER2 expression in patients with breast cancer. Thirty patients with pathologically confirmed breast cancer were recruited and imaged with both 99mTc-NM-02 SPECT/computed tomography (CT) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT. According to the treatment conditions before recruitment, patients were divided into two groups, the newly diagnosed group (n = 24) and the treated group (n = 6). The maximal standard uptake value (SUVmax) of 18F-FDG and SUVmax and mean SUV (SUVmean) of 99mTc-NM-02 in the lesions were determined to analyze the relationship with HER2 expression. No meaningful relationship was observed between 18F-FDG uptake and HER2 expression in 30 patients with breast cancer. 99mTc-NM-02 uptake was positively correlated with HER2 expression in the newly diagnosed group, but no correlation was observed in the treated group. 99mTc-NM-02 uptake in HER2-positive lesions was lower in those with effective HER2-targeted therapy compared with the newly diagnosed group. 99mTc-NM-02 SPECT/CT detected brain and bone metastases of breast cancer with a different imaging pattern from 18F-FDG PET/CT. 99mTc-NM-02 showed no non-specific uptake in inflamed tissues and revealed intra- and intertumoral HER2 heterogeneity by SPECT/CT imaging in 9 of the 30 patients with breast cancer. 99mTc-NM-02 SPECT/CT has the potential for visualizing whole-body HER2 overexpression in untreated patients, making it a promising method for HER2 assessment in patients with breast cancer. NCT04674722, Date of registration: December 19, 2020.

更新日期：2024-03-08

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