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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Diagnostic test: Ultrasound light scattering imaging equipment

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Xiao-Feng Zhang, PhD; Phone Number: 18778035342; Email: 562438747@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Xin-Wu Cui
      • Contact: Xin-Wu Cui, PhD,MD; Phone Number: 15927103161; Email: cuixinwu@live.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

In order to verify that ultrasound light scattering imaging technology can help in the differential diagnosis of benign and malignant breast nodules. For subjects who meet the inclusion criteria, breast nodules will be examined by traditional ultrasound and ultrasonic light scattering imaging, and the diagnostic efficacy of both will be determined based on the final pathological results of the subjects.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Whether to use ultrasound light scattering imaging equipment	Diagnostic test: Ultrasound light scattering imaging equipment; Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules
Conventional ultrasound
Device Assistant physician	Diagnostic test: Ultrasound light scattering imaging equipment; Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benign breast tumor	Pathological diagnosis	Up to 12 months
Malignant breast tumor	Pathological diagnosis	Up to 12 months
Breast lymph node metastasis	Pathological diagnosis	Up to 12 months
No lymph node metastasis	Pathological diagnosis	Up to 12 months

Collaborators and Investigators

• Sponsor: Xin-Wu Cui
• Collaborators: Hubei Cancer Hospital; First Affiliated Hospital of Kunming Medical University; Guangxi National Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 16, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Artificial intelligence; Metastasis; Ultrasonic light scattering imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2024(S044)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No