Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gek Kwan-Lim
ORCID ID
Contact details
Section of Magnetic Resonance
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 208 661 3720
gek.kwan-lim@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
850; G9600413
Study information
Scientific title
National multicentre study of magnetic resonance imaging (MRI) as a method of screening for breast cancer in women at genetic risk
Acronym
MARIBS
Study hypothesis
This is a national multicentre study of magnetic resonance imaging (MRI) as a method of screening for breast cancer in women at genetic risk. The study was developed in response to an invitation from the MRC in the UK to address Priority L of the NHS R and D Priorities in Cancer. The sensitivity and specificity of contrast enhanced MRI will be compared with two-view X-ray mammography in a comparative trial.
Approximately 500 women below the age of 50 at high genetic risk of breast cancer will be recruited per year for three years, with annual MRI and X-ray examination continuing for up to five years. A symptomatic cohort will be measured in the first year to establish common criteria for scoring and to ensure consistent practice. Women will be followed up to ascertain the true rate of breast cancer. The MRI examination will comprise an initial high sensitivity screening measurement, followed by a high specificity dynamic measurement in equivocal cases.
In addition to morphological assessment, the kinetics of contrast agent uptake will be measured, and quantitative pharmacokinetic parameters will be derived, to allow the most specific indicators of malignancy to be identified for subsequent routine use. Mammography, localisation, pathology and cytology will be performed in accordance with the NHS Breast Screening Programme quality assurance standards. Similar standards of quality assurance will be applied for MRI measurements and evaluation. The psychological impact and health economics of screening with both modalities in this high-risk group will be ascertained.
Ethics approval
North Thames Multi-centre Research Ethics Committee approved on the 11th November 1998 (ref: MREC/98/2/38)
Study design
Multicentre non-randomised observational screening genetic epidemiology study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention
A symptomatic cohort will be measured in the first year to establish common criteria for scoring and to ensure consistent practice. Women will be followed up to ascertain the true rate of breast cancer. The MRI examination will comprise an initial high sensitivity screening measurement, followed by a high specificity dynamic measurement in equivocal cases. In addition to morphological assessment, the kinetics of contrast agent uptake will be measured, and quantitative pharmacokinetic parameters will be derived.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Annual MRI and x-ray breast examination
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1997
Overall trial end date
31/03/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Group 1:
1. Women aged 35 - 49 years
2. Tested BRCA1 or BRCA2 carriers
3. Known mutation in first degree relative
4. Family history of breast and ovarian cancer (four or more relatives)
Group 2:
1. Women aged 25 - 49 years
2. Tested p53 carriers
3. Known mutation in a first degree relative
4. Family history consistent with Li Frameni syndrome
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned sample size: 900
Participant exclusion criteria
1. Previous breast cancer (including ductal carcinoma in situ [DCIS])
2. Terminal illness, or life expectancy of less than 5 years
3. Pregnancy or breast-feeding (recruitment suspended until breast-feeding has finished)
4. Current chemotherapy (recruitment suspended until 6 months after treatment ceases; exclusion 2, above, still applies)
Recruitment start date
01/04/1997
Recruitment end date
31/03/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Magnetic Resonance
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
222 Euston Road
London
NW1 2DA
United Kingdom
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G9600413)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25534390