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Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography: A Multicenter Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06468566
Enrollment
2000
Registered
2024-06-21
Start date
2024-02-01
Completion date
2026-02-28
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Keywords

Ultrasonic light scattering imaging, Breast Cancer, Metastasis, Artificial intelligence

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.

Interventions

DIAGNOSTIC_TESTUltrasound light scattering imaging equipment

Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules

Sponsors

Hubei Cancer Hospital
CollaboratorOTHER
Guangxi National Hospital
CollaboratorUNKNOWN
First Affiliated Hospital of Kunming Medical University
CollaboratorOTHER
Xin-Wu Cui
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Benign breast tumorUp to 12 monthsPathological diagnosis
Malignant breast tumorUp to 12 monthsPathological diagnosis
Breast lymph node metastasisUp to 12 monthsPathological diagnosis
No lymph node metastasisUp to 12 monthsPathological diagnosis

Countries

China

Contacts

Primary ContactXiao-Feng Zhang, PhD
562438747@qq.com18778035342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026