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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468566
• Other study ID #: 2024(S044)
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: Tongji Hospital
• Contact: Xiao-Feng Zhang, PhD
• Phone: 18778035342
• Email: 562438747[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 28, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Diagnostic Test:
• Ultrasound light scattering imaging equipment
Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules

Locations

Country	Name	City	State
China	Xin-Wu Cui	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Xin-Wu Cui	First Affiliated Hospital of Kunming Medical University, Guangxi National Hospital, Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Di Sciacca G, Maffeis G, Farina A, Dalla Mora A, Pifferi A, Taroni P, Arridge S. Evaluation of a pipeline for simulation, reconstruction, and classification in ultrasound-aided diffuse optical tomography of breast tumors. J Biomed Opt. 2022 Mar;27(3):036003. doi: 10.1117/1.JBO.27.3.036003. — View Citation

Huang Y, Cua M, Brake J, Liu Y, Yang C. Investigating ultrasound-light interaction in scattering media. J Biomed Opt. 2020 Feb;25(2):1-12. doi: 10.1117/1.JBO.25.2.025002. — View Citation

Zhu Q, Ricci A Jr, Hegde P, Kane M, Cronin E, Merkulov A, Xu Y, Tavakoli B, Tannenbaum S. Assessment of Functional Differences in Malignant and Benign Breast Lesions and Improvement of Diagnostic Accuracy by Using US-guided Diffuse Optical Tomography in Conjunction with Conventional US. Radiology. 2016 Aug;280(2):387-97. doi: 10.1148/radiol.2016151097. Epub 2016 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benign breast tumor	Pathological diagnosis	Up to 12 months
Primary	Malignant breast tumor	Pathological diagnosis	Up to 12 months
Primary	Breast lymph node metastasis	Pathological diagnosis	Up to 12 months
Primary	No lymph node metastasis	Pathological diagnosis	Up to 12 months