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

National Screening i Danmark Med MR-scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: MR mammography; Procedure: MR

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
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ilse Vejborg, MD; Phone Number: 45-35-451-662; Email: Ilse.Vejborg@regionh.dk
• Study Contact Backup: Name: Carsten Conrad, MD; Email: sve.cgc@nja.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100 Copenhagen Ø
    • Recruiting
    • Department of Radiology,Copenhagen University Hospital Rigshospitalet
    • Principal Investigator: Ilse Vejborg, MD
  • Esbjerg, Denmark
    • Recruiting
    • Department of Radiology, Esbjerg Sygehus
    • Principal Investigator: Stig M Nielsen, MD
  • Hjørring, Denmark
    • Recruiting
    • Department of Radiology, Sygehus Vendsyssel
    • Principal Investigator: Carsten Conrad, MD
  • Svendborg, Denmark
    • Recruiting
    • Department of Radiology, Svendborg Sygehus
    • Principal Investigator: Leslie Christensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Comparison of MR and mammography	Procedure: MR mammography; MR mammography; Procedure: MR; MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.	3 years
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.	3 years

Collaborators and Investigators

• Sponsor: Danish Breast Cancer Cooperative Group
• Investigators: Principal Investigator: Ilse Vejborg, MD, Danish Breast Cancer Cooperative Group

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 14, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 19, 2006

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Breast Cancer; Magnetic Resonance Imaging; Ultrasonography; Mammography; BRCA1 gene; BRCA2 gene
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DBCG07MRBRCA