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Sponsored by: |
Danish Breast Cancer Cooperative Group |
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Information provided by: | Danish Breast Cancer Cooperative Group |
ClinicalTrials.gov Identifier: | NCT00413491 |
The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: MR mammography Procedure: MR |
Phase IV |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | National Screening i Danmark Med MR-Scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer |
Estimated Enrollment: | 300 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Comparison of MR and mammography
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Procedure: MR mammography
MR mammography
Procedure: MR
MR
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Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study
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 predictive values.
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.
Ages Eligible for Study: | 25 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ilse Vejborg, MD | 45-35-451-662 | rh02727@rh.dk |
Contact: Carsten Conrad, MD | sve.cgc@nja.dk |
Denmark | |
Department of Radiology,Copenhagen University Hospital Rigshospitalet | Recruiting |
Copenhagen, Denmark, DK-2100 Copenhagen Ø | |
Principal Investigator: Ilse Vejborg, MD | |
Department of Radiology, Sygehus Vendsyssel | Recruiting |
Hjørring, Denmark | |
Principal Investigator: Carsten Conrad, MD | |
Department of Radiology, Svendborg Sygehus | Recruiting |
Svendborg, Denmark | |
Principal Investigator: Leslie Christensen, MD | |
Department of Radiology, Esbjerg Sygehus | Recruiting |
Esbjerg, Denmark | |
Principal Investigator: Stig M Nielsen, MD |
Principal Investigator: | Ilse Vejborg, MD | Danish Breast Cancer Cooperative Group |
Responsible Party: | ( Danish Breast Cancer Cooperative Group ) |
Study ID Numbers: | DBCG07MRBRCA, DBCG07MRBRCA |
Study First Received: | December 14, 2006 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00413491 |
Health Authority: | Denmark: Ethics Committee |
Breast Cancer BRCA1 gene BRCA2 gene |
Magnetic Resonance Imaging Mammography Ultrasonography |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |