Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor

The accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician's skill level, and the accuracy of breast examinations by non-experts is particularly low. In this study, we aimed to validate whether the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose of improving the sensitivity of detecting breast masses through breast examination.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Artificial Intelligence Benign Breast Disease Breast Diseases Breast Neoplasm Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Respiratory Tract Diseases Skin Diseases Skin and Connective Tissue Diseases Ultrasonography

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

[Background] This research team would like to conduct this study based on the idea that the sensitivity of breast palpation can be improved by moving away from traditional breast palpation, which is simply performed by hand, and using auxiliary examination equipment based on ultrasonic sensor technology. In particular, our research team focused on the waveform of the ultrasound itself rather than the visual images obtained through the ultrasound device. In the existing breast ultrasound, the medical staff reads images created through ultrasound from multiple sensors to confirm the possibility of breast cancer, and this is read based on the medical staff's very subjective opinions. However, ultrasonic waveforms acquired through ultrasound can store information about the waveform as data and thus be implemented as objective values.

[Study design] Prospective, multi-institutional

[Study protocol]

① Preoperative ultrasound sensor-based diagnostic equipment was applied to 200 patients with breast mass among patients admitted to the breast surgery department, and prospectively obtained ultrasound echo signal data generated by the mass.

② For this purpose, the researcher uses equipment containing a single ultrasound sensor to manually scan the mass lesion area and no evidence disease area.

③ Diagnostic performance (judgment for presence or absence of a tumor) of diagnostic tool based on ultrasound sensor technology through an artificial intelligence algorithm designed based on ultrasound wavelength and frequency optimized for mass detection.

[Objectives]

Primary endpoint Sensitivity/specificity/predictive value/accuracy/positive & negative predictive of diagnostic performance
Secondary endpoint Artificial intelligence algorithm efficacy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination

Exclusion criteria

Patients diagnosed with breast cancer after biopsy with non-mass enhancement or calcification
Inflammatory breast cancer
Patients whose cancer has invaded the skin and broken through
Patients with skin diseases
Women who refused to participate in the study

Treatment and study plan

Primary outcomes

Device performance

Time frame: Within 1 year after the study participant registration deadline

Sensitivity/specificity/predictive value/accuracy/positive predictive value/ negative predictive value of diagnostic performance

Secondary outcomes

Artificial intelligence algorithm efficacy

Time frame: Within 2 year after the study participant registration deadline

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor : A Development and Validation Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 13, 2024
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting