Multi-center Study of Deep Learning AI in Breast Mass

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Device: Yizhun BUSMS

Study type: Observational

Funder types: Other

Identifiers

NCT05443672

NCC2962

Details and patient eligibility

About

This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Full description

As the most common cancer expected to occur all over the world, extensive population screening plays a very important role in the early diagnosis and prognosis of the breast cancer. X-ray and ultrasound are the most commonly used screening methods, and ultrasound is especially important for Asian women with dense breasts. However, ultrasound is greatly affected by the operator's skill and experience, and the diagnostic accuracy varies greatly.

Artificial intelligence (AI) is a new method emerging in recent years, active in many medical fields and can effectively improve the diagnostic efficiency. However, previous researches on the application of AI in ultrasound are focused on single or multi-modality static ultrasound images. This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Enrollment: 1,122 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females who undergo ultrasound examination for a complaint of breast lesion;
2. The breast lesion that will obtain definite pathological diagnosis or follow-up at least two years.

Exclusion criteria

1. The breast lesion that has received CNB or FNA;
2. The breast cancer patient who has received neoadjuvant chemotherapy.