Breast CancerPhase 4MR BRCANCT00413491
National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations
A Phase 4 study testing MR mammography and MR in people with Breast Cancer, run by Danish Breast Cancer Cooperative Group at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MR mammography and MR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesDenmark
- Study dates
- Jan 2007to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women tested positive of BRCA1 or BRCA2 gene mutations
- referred for screening
- aged 25 - 70 years
Who cannot join
- general contraindications for MR
- pregnant or lactating
- men
- bilateral mastectomy
- ongoing treatment with chemotherapy
- metastatic breast cancer
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Carsten Conrad, MD contact
Denmark4 sites, 4 recruiting
- Recruiting
Department of Radiology,Copenhagen University Hospital Rigshospitalet
Copenhagen, DK-2100 Copenhagen Ø
Ilse Vejborg, MD
- Recruiting
Department of Radiology, Esbjerg Sygehus
Esbjerg
Stig M Nielsen, MD
- Recruiting
Department of Radiology, Sygehus Vendsyssel
Hjørring
Carsten Conrad, MD
- Recruiting
Department of Radiology, Svendborg Sygehus
Svendborg
Leslie Christensen, MD
About this 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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- MR mammography, MR
- Keywords
- Breast Cancer, BRCA1 gene, BRCA2 gene, Magnetic Resonance Imaging, Mammography, Ultrasonography
- Medical subject headings
- Breast Neoplasms, Fanconi Anemia, Complementation Group D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR mammographyProcedure or surgery
MR mammography
MRProcedure or surgery
MR
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comparison of MR and mammography Receives: Procedure: MR mammography; Procedure: MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Ilse Vejborg, MD, Principal investigator, Danish Breast Cancer Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413491
- Sponsor's protocol ID
- DBCG07MRBRCA
- Other IDs
- DBCG07MRBRCA
- Acronym
- MR BRCA
- Status last verified
- Jan 2009
- First submitted
- 14 Dec 2006
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00413491
- Acronym / sponsor ID
- MR BRCA / DBCG07MRBRCA
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, BRCA1 gene, BRCA2 gene, Magnetic Resonance Imaging, Mammography, Ultrasonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: MR mammography, Procedure: MRComparison of MR and mammography |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women tested positive of BRCA1 or BRCA2 gene mutations
- referred for screening
- aged 25 - 70 years
Key exclusion criteria (9 listed)
- general contraindications for MR
- pregnant or lactating
- men
- bilateral mastectomy
- ongoing treatment with chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR mammographyMR mammography | Procedure or surgery | 1 |
| MRMR | Procedure or surgery | 1 |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Conrad, MD contact
Ilse Vejborg, MD principal investigator
Danish Breast Cancer Cooperative Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MR mammography and MR in people with Breast Cancer, run by Danish Breast Cancer Cooperative Group at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilse Vejborg, MD (45-35-451-662, Ilse.Vejborg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.