Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening

Not Applicable

Completed

• Conditions: Breast Cancer; Screening
• Interventions: Device: Routine breast ultrasound; Device: AI-assisted breast ultrasound

• Registration Number: NCT06521788
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21790

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine screening	Routine breast ultrasound	Participants aged 35-70 years will be screened for breast cancer with routine B-ultrasound by experienced primary care physicians.
AI assisted B-ultrasound breast cancer screening	AI-assisted breast ultrasound	Participants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound

Primary Outcome Measures

Name	Time	Method
Incidence rate of early breast cancer in each arm	4 years	Early cancers should meet any of the following criteria at the time of diagnosis: less than 20 milimeters in diameter, no metastatic lymph nodes in the axilla, no distant metastasis, non-invasive cancers, stage 0, stage I, and stage IIa IIb (T2N1M0) breast cancer according to American Joint Committee on Cancer (AJCC) 8th staging.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods	4 years	A true-positive screening result (sensitivity) was a positive result in a participant who was diagnosed with breast cancer by further diagnostic work-up. A false-positive screening result was a positive result in the absence of breast cancer. A true-negative screening result (specificity) was a negative result in the absence of breast cancer and a false-negative test result was a negative result followed by diagnosis of interval cancer.

Trial Locations

Locations (3)

Maternal and Infant Healthy Centre of Hongkou District, Shanghai; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong New Area Healthcare Hospital For Women & Children; 🇨🇳 Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China