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National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations (MR BRCA)

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ClinicalTrials.gov Identifier: NCT00413491
Recruitment Status : Unknown
Verified January 2009 by Danish Breast Cancer Cooperative Group.
Recruitment status was:  Recruiting
First Posted : December 19, 2006
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Danish Breast Cancer Cooperative Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: MR mammography Procedure: MR Phase 4

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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
Study Start Date : January 2007
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Comparison of MR and mammography
Procedure: MR mammography
MR mammography
Procedure: MR
MR



Primary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue. [ Time Frame: 3 years ]
  2. 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. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women tested positive of BRCA1 or BRCA2 gene mutations
  • referred for screening
  • aged 25 - 70 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413491


Contacts
Contact: Ilse Vejborg, MD 45-35-451-662 Ilse.Vejborg@regionh.dk
Contact: Carsten Conrad, MD sve.cgc@nja.dk

Locations
Denmark
Department of Radiology,Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100 Copenhagen Ø
Principal Investigator: Ilse Vejborg, MD         
Department of Radiology, Esbjerg Sygehus Recruiting
Esbjerg, Denmark
Principal Investigator: Stig M Nielsen, 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         
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Investigators
Principal Investigator: Ilse Vejborg, MD Danish Breast Cancer Cooperative Group

Responsible Party: Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00413491     History of Changes
Other Study ID Numbers: DBCG07MRBRCA
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: January 2009

Keywords provided by Danish Breast Cancer Cooperative Group:
Breast Cancer
BRCA1 gene
BRCA2 gene
Magnetic Resonance Imaging
Mammography
Ultrasonography