MRI Clinical Trial
Official title:
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
This is a combination retrospective/prospective observational study with two arms:
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
BRCA1 and BRCA2 mutation carriers have a significant cumulative lifetime risk of developing
breast cancer, estimated to be 65% and 45%, respectively by the age of 70 [42]. NICE
guidelines recommend that these high risk women receive annual MRI screening from the age of
30, with the addition of annual XRM from the age of 40. At 50, continuation of MRI screening
is dependent on breast density [43][44]. The Royal Marsden NHS Foundation Trust screened a
large number of these women until 2013, when they were repatriated back into the NHS Breast
Screening Service. At St George's Hospital NHS Trust, screening is currently taking place as
a part of the NHS Breast Screening Service. Investigators will retrospectively analyse MRI
and XRM examinations from women who were aged between 40 and 50 years at screening.
Cohort 3: Participants attending MRI & XRM for breast screening post mantle radiotherapy
Environmental risk of breast cancer
Treatment with high dose mantle radiotherapy at a young age also confers a much higher risk
of breast cancer than that of the general population, estimated to result in an increased
relative risk of 14.4 in comparison with the general population. NICE guidelines recommend
that these high risk women receive annual MRI screening from the age of 30, with the addition
of annual XRM from the age of 40. At 50, continuation of MRI screening is dependent on breast
density. The Royal Marsden NHS Foundation Trust screened a large number of these women until
2013, when they were repatriated back into the NHS Breast Screening Service. At St George's
Hospital NHS Trust, screening is currently taking place as a part of the NHS Breast Screening
Service. Investigators will retrospectively analyse MRI and XRM examinations from women who
were aged between 40 and 50 years at screening.
Cohort 4: General population attending XRM for breast investigation Population risk of breast
cancer
Symptomatic women within the general population are referred to the Rapid Diagnostic and
Assessment Centre (RDAC) for breast investigations. A series of diagnostic tests are
performed at the RDAC which can include XRM if the women are 40 years of age or above. MRI is
not normally performed in this setting. Significant numbers of these women are found to have
normal breast tissue at XRM. These are women who have a population (low) risk of breast
cancer but who might potentially benefit from an MRI investigation. Investigators will
prospectively invite these women for a clinical MRI breast screening examination.
The aim of this study is to develop quantitative MRI measurements of breast tissue from
clinical MRI breast protocols and to demonstrate that these descriptors have potential value
for breast cancer risk prediction.
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