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

NCT06255808 | Active Not Recruiting DMC

• 1 other identifier: 2209-039-1357
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Neoplasm; Artificial Intelligence; Ultrasonography; Benign Breast Disease

Outcome Measures

Primary Outcomes (1)

• Device performance

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

  Within 1 year after the study participant registration deadline

Secondary Outcomes (1)

• Artificial intelligence algorithm efficacy

  Within 2 year after the study participant registration deadline

Study Arms (1)

Ultrasonic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

scheduled for surgery after a tumor has been confirmed on breast ultrasound examination

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: October 5, 2024
• Primary Completion: February 27, 2025
• Study Completion: April 5, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)