跳至主要内容
临床试验/NCT04097366
NCT04097366进行中(未招募)不适用

Breast Screening - Risk Adaptive Imaging for Density

University of Cambridge10 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2019年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
9,000
试验地点
10
主要终点
Cancer detection rate in each arm

研究概览

简要总结

BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

详细描述

Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Willing and able to give written informed consent
  • •Willing and able to comply with the scheduled study visits, tests and other procedures
  • •Screening mammogram that is either normal or being recalled for assessment
  • •Increased breast density identified on current screening mammogram examination (BIRADS C or D)
  • •If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant
  • •All BIRADS D will be eligible
  • •Aged 50-70 and eligible for 3-yearly NHS breast screening

排除标准

  • •Known BRCA carrier or ≥50% risk of being a carrier
  • •Unable to give informed consent
  • •Breast implant(s)
  • •Unable to be followed-up for the study duration
  • •Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)
  • •Participated in part A of the BRAID study
  • •Pregnant or breast feeding

研究组 & 干预措施

Standard of Care

No Intervention

Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.

Abbreviated MRI (ABB-MRI)

Active Comparator

Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.

干预措施: ABB-MRI (Diagnostic Test)

Automated Breast Ultrasound (ABUS)

Active Comparator

Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.

干预措施: ABUS (Diagnostic Test)

Contrast Enhanced Mammography (CEM)

Active Comparator

Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

干预措施: CEM (Diagnostic Test)

结局指标

主要结局

Cancer detection rate in each arm

时间窗: 42 months after mammogram at study entry

All cancers (detected or interval) in each arm over a three year period will be collected.

次要结局

  • Reading time of each examination(1 year)
  • The risk of developing breast cancer as assessed by the BOADICEA model(72 months After last participant entered)
  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(42 months after last participant entered)
  • Automated breast density measurements compared with reader assessment(Baseline)
  • Incidence of stage II or worse cancers over the period of observation(42 months after last participant entered)
  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(6 months after mammogram at study entry)
  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(21 months after mammogram at study entry)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiona J Gilbert

Professor of Radiology and Head of Department

University of Cambridge

研究点 (10)

Loading locations...

相似试验