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Clinical Trials/NCT06468566
NCT06468566
Recruiting
Not Applicable

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

Xin-Wu Cui1 site in 1 country2,000 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Xin-Wu Cui
Enrollment
2000
Locations
1
Primary Endpoint
Malignant breast tumor
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
February 28, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Xin-Wu Cui
Responsible Party
Sponsor Investigator
Principal Investigator

Xin-Wu Cui

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Malignant breast tumor

Time Frame: Up to 12 months

Pathological diagnosis

Benign breast tumor

Time Frame: Up to 12 months

Pathological diagnosis

Breast lymph node metastasis

Time Frame: Up to 12 months

Pathological diagnosis

No lymph node metastasis

Time Frame: Up to 12 months

Pathological diagnosis

Study Sites (1)

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