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Completed

NCT Number: NCT06521788

Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Screening Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Infant Healthy Centre of Hongkou District, Shanghai, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-assisted breast ultrasound

Device

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

Routine breast ultrasound

Device

Routine breast ultrasound conducted by primary care physicians

Primary outcomes

  1. Incidence rate of early breast cancer in each arm

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Application Research of B-ultrasound Assisted by Artificial Intelligence in Breast Cancer Screening

Acronym: AIBU

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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