使用 99mTc-NM-02 纳米抗体检测乳腺癌患者的 HER2 表达:一项非随机、非盲法临床试验。

IF 5.6 1区 医学 Q1 Medicine Breast Cancer Research Pub Date : 2024-03-08 DOI:10.1186/s13058-024-01803-y
Lingzhou Zhao, Yan Xing, Changcun Liu, Shaofei Ma, Wenhua Huang, Zhen Cheng, Jinhua Zhao
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引用次数: 0

摘要

背景:99m锝放射性标记纳米抗体NM-02(99m锝-NM-02)是一种新型单光子发射计算机断层扫描(SPECT)探针,对人类表皮生长因子受体2(HER2)具有高亲和力和特异性。本研究进行了一项临床成像试验,以探讨乳腺癌患者的 99mTc-NM-02 摄取与 HER2 表达之间的关系:方法:招募 30 名经病理确诊的乳腺癌患者,对其进行 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 扫描。根据入组前的治疗情况,将患者分为两组,即新诊断组(n = 24)和治疗组(n = 6)。测定病灶中 18F-FDG 最大标准摄取值(SUVmax)和 99mTc-NM-02 的 SUVmax 和平均 SUV(SUVmean),分析与 HER2 表达的关系:结果:在30例乳腺癌患者中,未观察到18F-FDG摄取与HER2表达之间存在有意义的关系。在新诊断组中,99m锝-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,接受过有效HER2靶向治疗的患者在HER2阳性病灶中的99m锝-NM-02摄取量较低。99mTc-NM-02 SPECT/CT 检测乳腺癌脑转移和骨转移的成像模式与 18F-FDG PET/CT 不同。99m锝-NM-02在炎症组织中未显示非特异性摄取,并通过SPECT/CT成像显示了30例乳腺癌患者中9例的瘤内和瘤间HER2异质性:结论:99m锝-NM-02 SPECT/CT具有在未经治疗的患者中观察全身HER2过度表达的潜力,使其成为乳腺癌患者HER2评估的一种有前途的方法:试验注册:NCT04674722,注册日期:2020 年 12 月 19 日:试验注册: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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: NCT04674722, Date of registration: December 19, 2020.

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来源期刊
CiteScore
12.00
自引率
0.00%
发文量
76
审稿时长
12 weeks
期刊介绍: Breast Cancer Research, an international, peer-reviewed online journal, publishes original research, reviews, editorials, and reports. It features open-access research articles of exceptional interest across all areas of biology and medicine relevant to breast cancer. This includes normal mammary gland biology, with a special emphasis on the genetic, biochemical, and cellular basis of breast cancer. In addition to basic research, the journal covers preclinical, translational, and clinical studies with a biological basis, including Phase I and Phase II trials.
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