NCT00413491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 20, 2014

Status Verified

January 1, 2009

Enrollment Period

8.4 years

First QC Date

December 14, 2006

Last Update Submit

May 19, 2014

Conditions

Breast Cancer

Keywords

Breast CancerBRCA1 geneBRCA2 geneMagnetic Resonance ImagingMammographyUltrasonography

Outcome Measures

Primary Outcomes (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.

    3 years

Secondary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Comparison of MR and mammography

Procedure: MR mammographyProcedure: MR

Interventions

MR mammographyPROCEDURE

MR mammography

1
MRPROCEDURE

MR

1

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Radiology,Copenhagen University Hospital Rigshospitalet

Copenhagen, DK-2100 Copenhagen Ø, Denmark

RECRUITING

Department of Radiology, Esbjerg Sygehus

Esbjerg, Denmark

RECRUITING

Department of Radiology, Sygehus Vendsyssel

Hjørring, Denmark

RECRUITING

Department of Radiology, Svendborg Sygehus

Svendborg, Denmark

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsFanconi Anemia, Complementation Group D1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ilse Vejborg, MD

    Danish Breast Cancer Cooperative Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilse Vejborg, MD

CONTACT

45-35-451-662Ilse.Vejborg@regionh.dk

Carsten Conrad, MD

CONTACT

sve.cgc@nja.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 19, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 20, 2014

Record last verified: 2009-01

Locations

DK(4)