UK Study of magnetic resonance imaging (MRI) for breast screening

ISRCTN	ISRCTN30587563
DOI	https://doi.org/10.1186/ISRCTN30587563
Secondary identifying numbers	850; G9600413

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 27/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Gek Kwan-Lim
Scientific

Section of Magnetic Resonance
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 208 661 3720
Email	gek.kwan-lim@icr.ac.uk

Study information

Study design	Multicentre non-randomised observational screening genetic epidemiology study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	National multicentre study of magnetic resonance imaging (MRI) as a method of screening for breast cancer in women at genetic risk
Study acronym	MARIBS
Study objectives	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(s)	North Thames Multi-centre Research Ethics Committee approved on the 11th November 1998 (ref: MREC/98/2/38)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Annual MRI and x-ray breast examination
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/1997
Completion date	31/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Planned sample size: 900
Key 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
Key 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)
Date of first enrolment	01/04/1997
Date of final enrolment	31/03/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Section of Magnetic Resonance

Sutton
SM2 5PT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

222 Euston Road
London
NW1 2DA
United Kingdom

Website	http://www.mrc.ac.uk/index.htm
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G9600413)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2015		Yes	No

Editorial Notes

27/11/2015: Publication reference added.