Breast CancerAIBUNCT06521788
Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening
A study testing AI-assisted breast ultrasound and Routine breast ultrasound in people with Breast Cancer and Screening, run by Fudan University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Screening
- What is being tested?
- AI-assisted breast ultrasound and Routine breast ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,790 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
China3 sites
Maternal and Infant Healthy Centre of Hongkou District, Shanghai
Shanghai, Shanghai Municipality, 200086
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Pudong New Area Healthcare Hospital For Women & Children
Shanghai
About this study
Official title: Application Research of B-ultrasound Assisted by Artificial Intelligence 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.
Read the 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.
- Conditions
- Breast Cancer, Screening
- Being tested
- AI-assisted breast ultrasound, Routine breast ultrasound
- Keywords
- Cancer epidemiology, Artificial intelligence, Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| AI assisted B-ultrasound breast cancer screening | Experimental | Participants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound Receives: 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. Receives: Device: Routine breast ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2020
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zheng, Fudan University
- Investigators
- Ying Zheng, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521788
- Sponsor's protocol ID
- 20210712
- Acronym
- AIBU
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
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.
PubMed 41057952
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of B-ultrasound Assisted by Artificial Intelligence in Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT06521788
- Acronym / sponsor ID
- AIBU / 20210712
- Conditions
- Breast Cancer, Screening
- Keywords
- Cancer epidemiology, Artificial intelligence, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,790 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI assisted B-ultrasound breast cancer screening | Experimental | Device: AI-assisted breast ultrasoundParticipants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound |
| routine screening | Active comparator | Device: Routine breast ultrasoundParticipants aged 35-70 years will be screened for breast cancer with routine B-ultrasound by experienced primary care physicians. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted breast ultrasoundAI-assisted breast ultrasound in community-based breast cancer screening | Device | AI assisted B-ultrasound breast cancer screening |
| Routine breast ultrasoundRoutine breast ultrasound conducted by primary care physicians | Device | routine screening |
Primary outcome
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.
1 secondary outcome
Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 41057952Shen 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.
- Individual participant dataSharing planned: Yes. We will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Zheng study chair
Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted breast ultrasound and Routine breast ultrasound in people with Breast Cancer and Screening, run by Fudan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of early breast cancer in each arm (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.