Exploring the Potential of Artificial Intelligence for Earlier Breast Cancer Detection: A Retrospective Multi-Reader Study Based on AI-Assisted Mammographic Interpretation (EARLIEST-AI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 785
- 试验地点
- 1
- 主要终点
- Standalone reader sensitivity
研究概览
简要总结
EARLIEST-AI Study type: Two-phase, multi-reader, blinded retrospective observational study based on data from a single clinic.
The primary objective of the study is to assess the sensitivity and specificity of radiologists and Artificial Intelligence (AI) in interpreting mammographic examinations for breast cancer detection in a scenario where no previous examinations are available, and to compare the diagnostic performance of radiologists with and without AI support.
The secondary objectives of the study are to assess the independent diagnostic performance of Computer Aided Detection (CAD) software, including sensitivity and specificity in identifying histopathologically confirmed breast cancer cases; to assess inter-reader and intra-reader variability in interpretation with and without AI support; to assess the agreement between AI outputs and histopathological findings; and to assess the impact of mammogram technical parameters on AI performance.
Time frame: Review of a subset of mammograms randomly selected from those performed between January 1, 2012 and December 31, 2024. Imaging findings were classified according to the Breast Imaging Reporting and Data System (BI-RADS).
Inclusion criteria:
- Female patients aged 30 years or older.
- One or more mammograms performed between January 1, 2012 and December 31, 2024.
- Meets one of the following criteria:
3.1 Histopathologically confirmed diagnosis of breast cancer within 6 months of mammogram, 3.2 or two consecutive mammograms with BI-RADS 1 or BI-RADS 2.
Exclusion criteria:
- Mammograms of poor quality or artifacts that do not allow for reliable assessment.
- History of breast surgery or previous breast cancer treatment that has significantly altered breast morphology.
- Data deficiencies, including:
3.1. lack of previous histopathological data 3.2. or lack of available follow-up data.
详细描述
DETAILED SUMMARY AND JUSTIFICATION OF THE PROPOSED RESEARCH Prophylactic mammograms are routinely performed on asymptomatic women every two years. During a preventive mammographic examination, four images are taken for each woman: two in the Craniocaudal (CC) projection and two in the Mediolateral Oblique (MLO) projection. Each time, the mammographic examination is evaluated using the Breast Imaging Reporting and Data System (BI-RADS).
In daily clinical practice at Mammograaf Radioloogiakliinik (AS Mammograaf), the BI-RADS system is used to evaluate mammographic examinations.
A BI-RADS 1 score is assigned to mammograms with no pathological changes. A BI-RADS 2 score indicates benign changes on mammograms.
In the presence of suspicious or malignant changes, a score of BI-RADS 3, BI-RADS 4 and/or BI-RADS 5 is assigned.
BI-RADS 6 is histopathologically confirmed breast cancer. The mammogram viewing protocol used in daily clinical practice at Mammograaf Radioloogiakliinik is presented below.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI-RADS 1-2 patients
BI-RADS 6 patients
结局指标
主要结局
Standalone reader sensitivity
时间窗: through study completion, an average of 1 year
Standalone CAD sensitivity
时间窗: through study completion, an average of 1 year
Augmented Reader sensitivity
时间窗: through study completion, an average of 1 year
Standalone reader detection to diagnostic time (MAE)
时间窗: through study completion, an average of 1 year
Augmented reader detection to diagnostic time (MAE)
时间窗: through study completion, an average of 1 year
次要结局
- Intra-reader agreement(through study completion, an average of 1 year)
- Standalone reader specificity(through study completion, an average of 1 year)
- Augmented reader specificity(through study completion, an average of 1 year)
- Inter-reader agreement(through study completion, an average of 1 year)
- Standalone reader markings region-wise annotation precision(through study completion, an average of 1 year)
- Augmented reader markings region-wise annotation precision(through study completion, an average of 1 year)
研究者
Marina Astapova
MD
Mammograaf Radioloogiakliinik