Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 4
- 主要终点
- Recall Rate in Group A Participants
研究概览
简要总结
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed.
Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence.
详细描述
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation.
A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 25 years of age or older;
- •No history of breast cancer;
- •Group A only: Asymptomatic and scheduled for screening mammography;
- •Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
- •Willing to provide a written informed consent.
排除标准
- •Pregnancy or intent to become pregnant;
- •Unable or unwilling to tolerate compression associated with mammography;
- •Breast implants;
- •Breasts too large to allow for adequate positioning for the DBT examination;
- •Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
- •Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
- •Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
- •Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).
研究组 & 干预措施
Group A: Screening
Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.
干预措施: Screening Tomosynthesis (Device)
Group B: Diagnostic Enriched Population
Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other).
干预措施: Diagnostic Tomosynthesis (Device)
结局指标
主要结局
Recall Rate in Group A Participants
时间窗: at the first imaging session
Each participant will undergo both FFDM and DBT examinations. Each of the two exams will be interpreted separately by readers at the participating sites and any positive finding for diagnostic followup will be considered a recall.
次要结局
- Accuracy Based on Pathology Results(at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome))
- Accuracy, Based on Pathology Results, by Lesion Classification(at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome))
- Callback Rate of Two-view Limited Tomosynthesis Set (With Low-dose MLO View Alone) With the Tomosynthesis Plus Set (Low-dose MLO View Plus Addition of Low-dose CC View)(At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure))
- Radiation Dose(at the first imaging session)
- Regression Model Parameters for Factors Effecting Radiation Dose(at the first imaging session)
- Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)(At the Diagnostic workup (within 30 Days After Screening))