Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening (AIBU)

Fudan University

Status: Completed

Conditions: Breast Cancer; Screening

Treatments: Device: Routine breast ultrasound; Device: AI-assisted breast ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06521788

20210712

Details and patient eligibility

About

AIBU is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according to the current local guidelines in each participating area) in detecting late-stage breast cancers.

Full description

we enrolled asymptomatic women Women From January 2021 to December 2022, and then followed up for the next 1 year. The main study endpoint will be measured at the end of the one year after intervention.

Enrollment: 21,790 patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 35-70 who participated in breast cancer screening (Shanghai Rural Women "Women two cancer screening project", national major public health service project "Rural women breast cancer screening Project" and "Gynecological diseases and breast diseases screening project for retired and living difficult women") in Shanghai district

Exclusion criteria

• 1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS); 2. Personal history of any types of malignant neoplasms; 3. Known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases; 4. Known condition or suspicion of serious comorbidities and average life expectancy less than 5 years; 5. History of lateral or bilateral mastectomy; 6. Disagree to participate in the study and follow-up interviews.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21,790 participants in 2 patient groups

AI assisted B-ultrasound breast cancer screening

Experimental group

Description:

Participants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound

Treatment:

Device: AI-assisted breast ultrasound

routine screening

Active Comparator group

Description:

Participants aged 35-70 years will be screened for breast cancer with routine B-ultrasound by experienced primary care physicians.

Treatment:

Device: Routine breast ultrasound