Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening

Fudan University21,790 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

21,790

Conditions

Breast Cancer Screening

Interventions

AI-assisted breast ultrasoundDEVICE

AI-assisted breast ultrasound in community-based breast cancer screening

Routine breast ultrasoundDEVICE

Routine breast ultrasound conducted by primary care physicians

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Maternal and Infant Healthy Centre of Hongkou District, Shanghai

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai Pudong New Area Healthcare Hospital For Women & Children

Shanghai, China

Outcomes

Primary Outcomes

Incidence rate of early breast cancer in each arm

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.

Time frame: 4 years

Secondary Outcomes

Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods

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.

Time frame: 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.