Li Jia, Chen Lei, Wang Ronghui, Zhu Jiang, Li Ao, Li Jianchun, Li Zhaojun, Luo Wen, Bai Wenkun, Ying Tao, Wei Cong, Sun Di, Zheng Yuanyi
Department of Ultrasound in Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Department of Ultrasound, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
BMC Med Imaging. 2025 Jan 8;25(1):13. doi: 10.1186/s12880-024-01535-7.
Benign and malignant breast tumors differ in their microvasculature morphology and distribution. Histologic biomarkers of malignant breast tumors are also correlated with the microvasculature. There is a lack of imaging technology for evaluating the microvasculature. Ultrasound localization microscopy (ULM) can provide detailed microvascular architecture at super-resolution. The objective of this trial is to explore the role of ULM in distinguishing benign from malignant breast tumors and to explore the correlations between ULM qualitative and quantitative parameters and histologic biomarkers in malignant breast tumors.
METHODS/DESIGN: This prospective and multicenter study will include 83 patients with breast tumors that will undergo ULM. 55 patients will be assigned to the malignant group, and 28 patients will be assigned to the benign group. The primary outcome is the differences in the qualitative parameters (microvasculature morphology, distribution, and flow direction) between benign and malignant breast tumors on ULM. Secondary outcomes include (1) differences in the quantitative parameters (microvasculature density, tortuosity, diameter, and flow velocity) between benign and malignant breast tumors based on ULM; (2) diagnostic performance of the qualitative parameters in distinguishing benign and malignant breast tumors; (3) diagnostic performance of the quantitative parameters in distinguishing benign and malignant breast tumors; (4) relationships between the qualitative parameters and histologic biomarkers in malignant breast tumors; (5) relationships between the quantitative parameters and histologic biomarkers in malignant breast tumors; and (6) the evaluation of inter-reader and intra-reader reproducibility.
Detecting vascularity in breast tumors is of great significance to differentiate benign from malignant tumors and to predict histologic biomarkers. These histologic biomarkers, such as ER, PR, HER2 and Ki67, are closely related to prognosis evaluation. This trial will provide maximum information about the microvasculature of breast tumors and thereby will help with the formulation of subsequent differential diagnosis and the prediction of histologic biomarkers.
TRIAL REGISTRATION NUMBER/DATE: Chinese Clinical Trial Registry ChiCTR2100048361/6th/July/2021. This study is a part of that clinical trial.
良性和恶性乳腺肿瘤在微血管形态和分布上存在差异。恶性乳腺肿瘤的组织学生物标志物也与微血管系统相关。目前缺乏评估微血管系统的成像技术。超声定位显微镜（ULM）能够以超分辨率提供详细的微血管结构。本试验的目的是探讨ULM在鉴别乳腺良性和恶性肿瘤中的作用，并探讨ULM定性和定量参数与恶性乳腺肿瘤组织学生物标志物之间的相关性。
方法/设计：这项前瞻性多中心研究将纳入83例接受ULM检查的乳腺肿瘤患者。55例患者将被分配到恶性组，28例患者将被分配到良性组。主要结局是ULM上乳腺良性和恶性肿瘤在定性参数（微血管形态、分布和血流方向）上的差异。次要结局包括：（1）基于ULM的乳腺良性和恶性肿瘤在定量参数（微血管密度、迂曲度、直径和血流速度）上的差异；（2）定性参数在鉴别乳腺良性和恶性肿瘤中的诊断性能；（3）定量参数在鉴别乳腺良性和恶性肿瘤中的诊断性能；（4）恶性乳腺肿瘤定性参数与组织学生物标志物之间的关系；（5）恶性乳腺肿瘤定量参数与组织学生物标志物之间的关系；（6）读者间和读者内重复性评估。
检测乳腺肿瘤中的血管对于鉴别良性和恶性肿瘤以及预测组织学生物标志物具有重要意义。这些组织学生物标志物，如雌激素受体（ER）、孕激素受体（PR）、人表皮生长因子受体2（HER2）和Ki67，与预后评估密切相关。本试验将提供关于乳腺肿瘤微血管系统的最大信息，从而有助于制定后续的鉴别诊断和预测组织学生物标志物。
试验注册号/日期：中国临床试验注册中心ChiCTR2100048361/2021年7月6日。本研究是该临床试验的一部分。
