- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684733
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer (MR-BTC)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arm 1: Cohort 1 - Retrospective Analysis
Participants attending MRI & XRM for a clinical indication with at least one normal breast
|
Clinical MRI breast screening examination
|
Arm 2: Cohort 2 - Retrospective Analysis
BRCA1 or BRCA2 mutation carriers attending MRI & XRM for breast screening: Genetic risk of breast cancer |
Clinical MRI breast screening examination
|
Arm 2: Cohort 3 - Retrospective Analysis
Participants attending MRI & XRM for breast screening post mantle radiotherapy: Environmental risk of breast cancer |
Clinical MRI breast screening examination
|
Arm 2: Cohort 4 - Prospective
General population attending XRM for breast investigation: Population risk of breast cancer MRI |
Clinical MRI breast screening examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After retrospective selection of subject groups (approximately 6 months).
|
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.
|
After retrospective selection of subject groups (approximately 6 months).
|
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.
|
Six months after recruitment
|
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.
|
Six months after recruitment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Allen, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR 4173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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