Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography: A Multicenter Study
NCT ID: NCT06468566
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2024-02-01
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Whether to use ultrasound light scattering imaging equipment
Ultrasound light scattering imaging equipment
Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules
Conventional ultrasound
No interventions assigned to this group
Device Assistant physician
Ultrasound light scattering imaging equipment
Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules
Interventions
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Ultrasound light scattering imaging equipment
Radiologists use ultrasound light scattering imaging to evaluate the benign and malignant nature of breast nodules
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
FEMALE
Yes
Sponsors
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Hubei Cancer Hospital
OTHER
Guangxi National Hospital
UNKNOWN
First Affiliated Hospital of Kunming Medical University
OTHER
Xin-Wu Cui
OTHER
Responsible Party
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Xin-Wu Cui
Professor
Locations
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Xin-Wu Cui
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2024(S044)
Identifier Type: -
Identifier Source: org_study_id
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