BRCA1 MutationMR-BTCNCT03684733
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a combination retrospective/prospective observational study with two arms: Read more about this study
- Who is it for?
- Ages 39 to 50 years, women only
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation, Mammography
- What is being tested?
- MRI
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2017to 15 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 50 years
- Women only
- Adult
Study population: Cohort 1: Retrospective breast MRI and XRM exam from participants with a clinical indication, reported as normal. Cohort 2: Retrospective breast MRI and XRM exams from genetically-proven BRCA1 or BRCA2 carriers; attendance at High Risk Breast Screening Service, RMH, and St George's Hospital (SGH). Cohort 3: Retrospective breast MRI and XRM exams from participants who received mantle radiotherapy at a young age and who subsequently attended the historic High Risk Breast Screening Service at RMH, or the High Risk Breast Screening Service at SGH. Cohort 4: Participants attending the RMH Rapid Diagnostic Assessment Centre for breast investigations who are found to have normal breast tissue on XRM will be prospectively invited for a breast MRI exam with administration of contrast agent.
Who may be able to join
- Cohort 1:
- Normal breast tissue in one or both breasts
- Aged > 39.5 years
- ≤ 6 months between XRM and MRI examinations
- Cohort 2:
- Genetically proven BRCA1 or 2 mutation carrier
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- Age 39.5 - 50.5 years
- ≤ 6 months between XRM and MRI examinations
- Cohort 3:
- Previous mantle radiotherapy
- Age 39.5 - 50.5 years
- ≤ 6 months between XRM and MRI examinations
- Cohort 4:
- Radiologically healthy breast tissue as assessed by XRM
- Age 39.5 - 50.5 years
- Able to attend MRI screening within 6 weeks of XRM
Who cannot join
- Cohort 1:
- Treatment or medication between XRM and MRI examinations
- Cohort 2:
- Previous breast cancer diagnosis and/or treatment
- Treatment or medication between XRM and MRI examinations
- Cohort 3:
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- Previous breast cancer diagnosis and/or treatment
- Treatment or medication between XRM and MRI examinations
- Cohort 4:
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
This is a combination retrospective/prospective observational study with two arms:
Read the 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.
- Conditions
- BRCA1 Mutation, BRCA2 Mutation, Mammography, MRI
- Being tested
- MRI
- Keywords
- Breast cancer, BRCA1/2 mutation carriers, Breast screening, Magnetic Resonance Imaging (MRI), X-ray mammography (XRM), Background Parenchymal Enhancement (BPE)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Clinical MRI breast screening examination
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Cohort 1 - Retrospective Analysis | Participants attending MRI \& XRM for a clinical indication with at least one normal breast Receives: Diagnostic Test: MRI | |
| Arm 2: Cohort 2 - Retrospective Analysis | BRCA1 or BRCA2 mutation carriers attending MRI \& XRM for breast screening:
Genetic risk of breast cancer Receives: Diagnostic Test: MRI | |
| Arm 2: Cohort 3 - Retrospective Analysis | Participants attending MRI \& XRM for breast screening post mantle radiotherapy:
Environmental risk of breast cancer Receives: Diagnostic Test: MRI | |
| Arm 2: Cohort 4 - Prospective | General population attending XRM for breast investigation:
Population risk of breast cancer MRI Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density
Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.
Measured: After retrospective selection of subject groups (approximately 6 months).
Arm 1 (Cohort 1), Arm 2 (Cohorts 2-3) : breast parenchyma enhancement (BPE)
BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.
Measured: After retrospective selection of subject groups (approximately 6 months).
Arm 2 (Cohort 4): breast density
Breast density is measured in standard clinical sequences and in research sequences, expected to be the gold standard, as a %volume.
Measured: Six months after recruitment
Arm 2 (Cohort 4): breast parenchyma enhancement (BPE)
BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.
Measured: Six months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start13 Mar 2017
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Allen, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684733
- Sponsor's protocol ID
- CCR 4173
- Acronym
- MR-BTC
- Status last verified
- Mar 2020
- First submitted
- 27 Apr 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
- ClinicalTrials.gov ID
- NCT03684733
- Acronym / sponsor ID
- MR-BTC / CCR 4173
- Conditions
- BRCA1 Mutation, BRCA2 Mutation, Mammography, MRI
- Keywords
- Breast cancer, BRCA1/2 mutation carriers, Breast screening, Magnetic Resonance Imaging (MRI), X-ray mammography (XRM), Background Parenchymal Enhancement (BPE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Cohort 1 - Retrospective Analysis | – | Diagnostic Test: MRIParticipants attending MRI \& XRM for a clinical indication with at least one normal breast |
| Arm 2: Cohort 2 - Retrospective Analysis | – | Diagnostic Test: MRIBRCA1 or BRCA2 mutation carriers attending MRI \& XRM for breast screening: Genetic risk of breast cancer |
| Arm 2: Cohort 3 - Retrospective Analysis | – | Diagnostic Test: MRIParticipants attending MRI \& XRM for breast screening post mantle radiotherapy: Environmental risk of breast cancer |
| Arm 2: Cohort 4 - Prospective | – | Diagnostic Test: MRIGeneral population attending XRM for breast investigation: Population risk of breast cancer MRI |
Who may qualify
- Ages
- 39 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Cohort 1: Retrospective breast MRI and XRM exam from participants with a clinical indication, reported as normal. Cohort 2: Retrospective breast MRI and XRM exams from genetically-proven BRCA1 or BRCA2 carriers; attendance at High Risk Breast Screening Service, RMH, and St George's Hospital (SGH). Cohort 3: Retrospective breast MRI and XRM exams from participants who received mantle radiotherapy at a young age and who subsequently attended the historic High Risk Breast Screening Service at RMH, or the High Risk Breast Screening Service at SGH. Cohort 4: Participants attending the RMH Rapid Diagnostic Assessment Centre for breast investigations who are found to have normal breast tissue on XRM will be prospectively invited for a breast MRI exam with administration of contrast agent.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIClinical MRI breast screening examination | Diagnostic test | Arm 1: Cohort 1 - Retrospective Analysis, Arm 2: Cohort 2 - Retrospective Analysis, Arm 2: Cohort 3 - Retrospective Analysis, Arm 2: Cohort 4 - Prospective |
Primary outcome
Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density
Time frame: 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.
Arm 1 (Cohort 1), Arm 2 (Cohorts 2-3) : breast parenchyma enhancement (BPE)
Time frame: 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 density
Time frame: 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 2 (Cohort 4): breast parenchyma enhancement (BPE)
Time frame: Six months after recruitment
BPE is measured as a % of pre-contrast image intensity on dynamic contrast-enhanced examinations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Allen principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1 (Cohort 1), Arm 2 (Cohorts 2 & 3) : breast density (time frame: After retrospective selection of subject groups (approximately 6 months).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.