Status:
UNKNOWN
National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
25-70 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 ou...
Eligibility Criteria
Inclusion
- women tested positive of BRCA1 or BRCA2 gene mutations
- referred for screening
- aged 25 - 70 years
Exclusion
- general contraindications for MR
- pregnant or lactating
- men
- bilateral mastectomy
- ongoing treatment with chemotherapy
- metastatic breast cancer
- previous breast surgery less than 6 months before MR
- previous radiation therapy of the breast less than 1 year before
- incapable of managing her own affairs
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00413491
Start Date
January 1 2007
End Date
June 1 2015
Last Update
May 20 2014
Active Locations (4)
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1
Department of Radiology,Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, DK-2100 Copenhagen Ø
2
Department of Radiology, Esbjerg Sygehus
Esbjerg, Denmark
3
Department of Radiology, Sygehus Vendsyssel
Hjørring, Denmark
4
Department of Radiology, Svendborg Sygehus
Svendborg, Denmark