Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icr.ac.uk/cmagres/maribs/maribs.html

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 measures

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

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

http://www.mrc.ac.uk/index.htm

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G9600413)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25534390

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.