National Screening i Danmark Med MR-Scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer
Study type : Interventional Study design: Diagnostic,Prospective,Non
Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):
Primary outcome measures:
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound
of the breast measured by accuracy, sensitivity, specificity, positive and negative
Secondary outcome measures:
Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women
with dense breast tissue compared with women with fatty breast tissue.
Comparison of the cancers found in women with BRCA gene mutations compared with the cancers
found in the background population in respect of morphology, size, histological type,
axillary lymph node status and grade.
Study start : January 2007. Expected completion 2010.
Women with BRCA gene mutations are more likely than others to develop the disease at a young
age when breast density is higher than at older age.The tumours often are more rapidly
developing with a short presymptomatic phase. These factors are known to reduce the
effectiveness of screening with mammography and mammography seems to have a low sensitivity
in women with BRCA gene mutations. Other studies have shown that more than 50% of the
cancers appears as interval cancers between two mammography screening examinations and many
have positive axillary nodes at the time of diagnosis.
Around 610 women are tested BRCA gene positive in Denmark in year 2006. These women are
offered a yearly screening with mammography combined with ultrasound and a clinical
examination. The trial will test whether this screening offer should be combined with or
replaced by MR mammography.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
Ilse Vejborg, MD
Danish Breast Cancer Cooperative Group
Denmark: Ethics Committee