Breast CancerNCT00588614
High Risk Screening Breast MR Using a Rapid Imaging Exam
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Feb 2011
- Phase
- Observational
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: breast clinic patients
Who may be able to join
- High risk for the development of breast cancer. For the purposes of this study high risk women will be defined as those having one of the following:
- One or more first degree blood relative(s), maternal or paternal, with known primary breast cancer, PLUS a Gail model calculated 5 year risk of greater than or equal to 1.67%
- First, and/or second degree blood relative(s) with a family history suggestive of a BRCA mutation (those families having a member(s) with primary breast cancer diagnosed at or before the age of 40, primary breast cancer and ovarian cancer within the same family or family member, male relative with primary breast cancer, a relative with bilateral breast cancer, or multiple generations of family members with primary breast and/or ovarian cancer)
- A known BRCA mutation
- A family member carrying a known BRCA mutation
- A personal history of a high risk breast lesion, including lobular carcinoma in situ and atypical hyperplasia
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- A personal history of primary breast cancer (invasive or in-situ) treated with unilateral mastectomy
- Patients must have a mammogram performed within the last 6 months, and the mammography images must be available for review at the time of the MR interpretation.
- Age 25-75
- Female
Who cannot join
- They are unable to return in one year for follow-up exam
- Medical history includes:
- Previous breast cancer treated with breast conservation
- History of benign excisional biopsy in the previous 24 months
- History of a benign core needle biopsy or FNA in the previous 12 months
- History of metastatic cancer
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- 45 minute prone scan cannot be tolerated
- Pregnant, as a mammogram for correlation with MR is required
- History of breast MR in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams.
Measured: 2 years
Secondary outcomes (1)
Secondary aim is to estimate the proportion of patients who go on to have a more comprehensive exam based on the results of the short exam.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionFeb 2011
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Investigators
- Elizabeth R DePeri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588614
- Sponsor's protocol ID
- 363-06
- Status last verified
- May 2012
- First submitted
- 26 Dec 2007
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Screening Breast MR Using a Rapid Imaging Exam
- ClinicalTrials.gov ID
- NCT00588614
- Acronym / sponsor ID
- 363-06
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Jan 2008 (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.
This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- breast clinic patients
Key inclusion criteria (10 listed)
- High risk for the development of breast cancer. For the purposes of this study high risk women will be defined as those having one of the following:
- Patients must have a mammogram performed within the last 6 months, and the mammography images must be available for review at the time of the MR interpretation.
- Age 25-75
- Female
Key exclusion criteria (9 listed)
- They are unable to return in one year for follow-up exam
- Medical history includes:
- 45 minute prone scan cannot be tolerated
- Pregnant, as a mammogram for correlation with MR is required
- History of breast MR in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams.
Time frame: 2 years
1 secondary outcome
Secondary aim is to estimate the proportion of patients who go on to have a more comprehensive exam based on the results of the short exam.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
Elizabeth R DePeri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams. (time frame: 2 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 30 May 2012.