Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening

NCT06521788 | Completed

• 1 other identifier: 20210712
• Study Type: interventional
• Target: 21,790
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Screening

Keywords

Cancer epidemiology; Artificial intelligence; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (1)

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

  4 years

Study Arms (2)

AI assisted B-ultrasound breast cancer screening

EXPERIMENTAL

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

Device: AI-assisted breast ultrasound

routine screening

ACTIVE COMPARATOR

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

Device: Routine breast ultrasound

Interventions

AI-assisted breast ultrasound DEVICE

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

AI assisted B-ultrasound breast cancer screening

Routine breast ultrasound DEVICE

Routine breast ultrasound conducted by primary care physicians

routine screening

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (3)

Maternal and Infant Healthy Centre of Hongkou District, Shanghai

Shanghai, Shanghai Municipality, 200086, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Shanghai Pudong New Area Healthcare Hospital For Women & Children

Shanghai, China

Location

Related Publications (1)

• Shen J, Liu Y, Liu A, Gu X, Zhou J, Jiang P, Mo M, Zhang L, Yang C, Zhou C, Wang Z, Xie Z, Yao W, Zhou S, Zheng Y, Chang C. Artificial intelligence-assisted ultrasound screening for breast cancer in China: a prospective, clustered, controlled, population-based study. Breast Cancer Res. 2025 Oct 7;27(1):173. doi: 10.1186/s13058-025-02128-0.

  PMID: 41057952 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ying Zheng

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Prevention Department, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data shared will be limit to that required for independent mandated verification of the published results. And the data will only be transferred after signing of a data access agreement.
• Access Criteria: The study chairman will consider access to study data upon written detailed request sent to her, from 6 months until 5 years after publication of summary data.

Locations

CN (3)