Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468566
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-10
Brief Title:
Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography A Multicenter Study
Sponsor:
Xin-Wu Cui
Organization:
Tongji Hospital
Study Overview
Official Title:
Identification of Benign and Malignant Breast Nodules Using Opalogram Ultrasonography A Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 examiners 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None