Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Arm 2 (Cohort 4): breast density
研究概览
简要总结
This is a combination retrospective/prospective observational study with two arms:
详细描述
Arm 1 :To establish the accuracy of MRI measurements from clinical MRI sequences
Cohort 1: Participants attending MRI & XRM for a clinical indication with at least one normal breast
Women attend MRI and XRM at the Royal Marsden NHS Foundation Trust for a wide range of clinical indications, including screening, staging and disease monitoring. Investigators will retrospectively analyse MRI and XRM examinations from women with at least one normal breast. This will enable a comparison of clinical and research MRI techniques to measure MRI Breast Density and BPE together with a correlation against PMD. This cohort should cover a wide range of ages and breast densities which will enable a useful comparison of measurement techniques.
Arm 2 To compare breast tissue between women at varying risk of breast cancer
Cohort 2: BRCA1 or BRCA2 mutation carriers attending MRI & XRM for breast screening Genetic risk of breast cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 39 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Normal breast tissue in one or both breasts
- •Aged > 39.5 years
- •≤ 6 months between XRM and MRI examinations
- •Genetically proven BRCA1 or 2 mutation carrier
- •Age 39.5 - 50.5 years
- •≤ 6 months between XRM and MRI examinations
- •Previous mantle radiotherapy
- •Age 39.5 - 50.5 years
- •≤ 6 months between XRM and MRI examinations
- •Radiologically healthy breast tissue as assessed by XRM
- •Age 39.5 - 50.5 years
- •Able to attend MRI screening within 6 weeks of XRM
排除标准
- •Treatment or medication between XRM and MRI examinations
- •Previous breast cancer diagnosis and/or treatment
- •Treatment or medication between XRM and MRI examinations
- •Previous breast cancer diagnosis and/or treatment
- •Treatment or medication between XRM and MRI examinations
- •Previous breast cancer diagnosis and/or treatment
- •MRI incompatible implants
- •Claustrophobia
- •Inability to tolerate a 40 minute MRI breast examination
- •Patients with renal failure or problems with IV access
结局指标
主要结局
Arm 2 (Cohort 4): breast density
时间窗: Six months after recruitment
Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.
Arm 1 (Cohort 1), Arm 2 (Cohorts 2-3) : breast parenchyma enhancement (BPE)
时间窗: After retrospective selection of subject groups (approximately 6 months).
BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.
Arm 2 (Cohort 4): breast parenchyma enhancement (BPE)
时间窗: Six months after recruitment
BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.
Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density
时间窗: After retrospective selection of subject groups (approximately 6 months).
Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.
次要结局
未报告次要终点