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

NCT06468566 | Recruiting

• 1 other identifier: 2024(S044)
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Whether to use ultrasound light scattering imaging equipment

Diagnostic Test: Ultrasound light scattering imaging equipment

Conventional ultrasound

Device Assistant physician

Diagnostic Test: Ultrasound light scattering imaging equipment

Interventions

Ultrasound light scattering imaging equipment DIAGNOSTIC_TEST

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

Device Assistant physician; Whether to use ultrasound light scattering imaging equipment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin-Wu Cui: lead
• Hubei Cancer Hospital: collaborator
• Guangxi National Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Xin-Wu Cui

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32103649 BACKGROUND

• 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.

  PMID: 35332743 BACKGROUND

• 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.

  PMID: 26937708 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiao-Feng Zhang, PhD

CONTACT

18778035342; 562438747@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 21, 2024
• Study Start: February 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)