Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-04 @ 8:35 AM
Study NCT ID:
NCT03684733
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2018-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MR-BTC
Brief Summary:
This is a combination retrospective/prospective observational study with two arms:
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: