Clinical trial · Interventional
Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening
Application Research of B-ultrasound Assisted by Artificial Intelligence in Breast Cancer Screening
NCT06521788CI-TRIAL-00079150AIBUcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted breast ultrasound | Device | — | UNRESOLVED |
| Routine breast ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI assisted B-ultrasound breast cancer screening
- description
- Participants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound
- interventionNames
- Device: AI-assisted breast ultrasound
- type
- ACTIVE_COMPARATOR
- label
- routine screening
- description
- Participants aged 35-70 years will be screened for breast cancer with routine B-ultrasound by experienced primary care physicians.
- interventionNames
- Device: Routine breast ultrasound
Primary outcomes (1)
- measure
- Incidence rate of early breast cancer in each arm
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShen 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