跳至主要内容
临床试验/NCT06468566
NCT06468566招募中不适用

Identification of Benign and Malignant Breast Nodules Using Opalogram Ultrasonography: A Multicenter Study

Xin-Wu Cui1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Malignant breast tumor

研究概览

简要总结

Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. This study aims to evaluate the value of ultrasonic light scattering imaging in the differential diagnosis of benign and malignant breast nodules, and to evaluate the consistency between ultrasonic light scattering imaging and examiners in the differential diagnosis of benign and malignant breast nodules.

详细描述

Breast cancer is the most common malignant tumor in women and the second leading cause of cancer death worldwide. Therefore, early detection and timely treatment of breast cancer are of great significance to controlling and reducing breast cancer mortality. Breast ultrasound has been widely used in the detection of breast cancer, but ultrasound is highly dependent on the examiner in terms of technology, and the examination results are greatly affected by the examiner's subjectivity, which increases unnecessary surgery and punctures, causing great trouble to clinicians and patients. Moreover, the value of conventional ultrasound in the differential diagnosis of breast masses is still limited, while the emergence of new technologies such as artificial intelligence and elastic imaging has improved the accuracy of ultrasound diagnosis to varying degrees.

The recently developed ultrasound light scattering imaging technology is used in breast ultrasound imaging systems to assist in morphological analysis based on the description and final evaluation of the Breast Imaging Reporting and Data System (BI-RADS), providing a new way to distinguish benign and malignant breast nodules.

Ultrasonic light scattering imaging technology is a new functional imaging technology that integrates traditional B-type ultrasound imaging and light scattering tomography (DOT). It uses B-type ultrasound to locate lesions and uses DOT to measure the concentrations of total hemoglobin, oxygenated hemoglobin and deoxygenated hemoglobin in diseased tissues based on the differences in the absorption rates of light of specific wavelengths in different tissues. It also measures the neovascularization at the tumor site and its potential local hypoxia stimulation. It introduces additional physiological information to current breast screening methods, often before morphological abnormalities. It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption in lesions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Had breast lesions detected by ultrasound Age 18 or older Upcoming FNAB or surgery Signing informed consent

排除标准

  • Patients who had received a biopsy of breast lesion before the ultrasound examination Can not cooperate with the test operation Patients who were pregnant or lactating Patients who were undergoing neoadjuvant treatment.

结局指标

主要结局

Malignant breast tumor

时间窗: Up to 12 months

Pathological diagnosis

Benign breast tumor

时间窗: Up to 12 months

Pathological diagnosis

Breast lymph node metastasis

时间窗: Up to 12 months

Pathological diagnosis

No lymph node metastasis

时间窗: Up to 12 months

Pathological diagnosis

次要结局

未报告次要终点

研究者

发起方
Xin-Wu Cui
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin-Wu Cui

Professor

Tongji Hospital

研究点 (1)

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