Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- Screen-detected breast cancers
研究概览
简要总结
The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.
详细描述
Independent double reading with consensus is the recommended practice for breast cancer screening programs in Europe. This is a time-consuming process and more than 99% of examinations are determined to have a negative final outcome in BreastScreen Norway. However, radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected and interval cancers to be visible at prior screening mammograms. In Norway and other countries, there is also a shortage of breast radiologists.
Retrospective studies on AI in mammographic screening have shown promising results in the classification of cancer negative and cancer positive examinations. However, prospective studies are needed to elucidate questions concerning AI as a support or replacement for the radiologists in the interpretation process.
In this randomized controlled trial women attending screening and consenting to participate in the study, will be randomized (1:1 allocation) to an intervention or a control group. The screening examination will be performed as usual in both groups. The intervention in the trial is the interpretation procedure.
All examinations will be analyzed by AI. In the intervention group, examinations will be triaged according to risk of malignancy defined by an AI score. Examinations with a low AI score (1-7) will have a single reading by one radiologist and examinations with a intermediate or high AI score (8-10) will have an independent double reading by two radiologists. All examinations selected by either one or both radiologist will be discussed at consensus. Examinations with an AI raw score of >9.8 will be discussed at consensus independent of the radiologists' interpretation. The radiologists will be blinded to whether the mammograms are interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious calcifications and masses are only provided to the radiologists at consensus, not during independent reading. In the control group, two independent radiologists will interpret all screening examinations according to standard procedure, independent double reading. AI results will not be available at either independent reading or consensus, only for comparison with the intervention group in final analyses.
Screen-detected cancers in the intervention and control arm will be analyzed in terms of non-inferiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
Neither the participant nor the radiologic technician performing the mammography examination will know to what study arm the participant was allocated. Radiologists reading the screening examinations will be blinded to the intervention at initial reading but not in the consensus meeting.
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
排除标准
- •Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
研究组 & 干预措施
Intervention arm
AI assisted mammography screening interpretation
干预措施: AI assisted mammography screening interpretation (Other)
Control arm
Standard mammography screening interpretation (standard procedure)
干预措施: Standard mammography screening interpretation (Other)
结局指标
主要结局
Screen-detected breast cancers
时间窗: 36 months from study start-up
Number of breast cancers detected at screening per 1000 screening examinations.
次要结局
- Interval breast cancers(60 months from study start-up)
- Prognostic and predictive tumor characteristics of screen-detected breast cancer(36 months from study start-up)
- Prognostic and predictive tumor characteristics of interval breast cancer(60 months from study start-up)
- Sensitivity(60 months from study start-up)
- Consensus rate(24 months from study start-up)
- Recall rate(24 months from study start-up)
- Specificity(60 months from study start-up)
- Mammographic features of screen-detected breast cancer(36 months from study start-up)
- Time spent screen-reading(36 months from study start-up)