- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475979
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
Study Purpose:
A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing
Study Scheme:
- AB-MR, US, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year.
- After completion of study, patients are followed-up for at least 1 year.
Study Overview
Status
Detailed Description
For women with a BRCA1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast MRI is recommended. For women who met BRCA testing criteria but show an uninformative negative result or a variant of unknown significance (VUS) result, there is no established recommendation for second breast cancer surveillance.
Abbreviated breast MRI (AB-MR) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast MRI. Breast ultrasound (US) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate MRI.
The purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with AB-MR or US in addition to annual mammography in women with BRCA1/2 mutation testing.
AB-MR, US, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. The BI-RADS category 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Woo Kyung Moon, MD, PhD
- Phone Number: 82-2-2072-2584
- Email: moonwk@snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Woo Kyung Moon, MD, PhD
- Email: moonwk1963@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women aged between 25 years and 75 years with a personal history of breast cancer
- BRCA mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives
- No symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction)
- Written informed consent is given
Exclusion criteria:
- Initial breast cancer stage IV
- Bilateral mastectomy done
- Diagnosis of second breast cancer or regional/distant metastasis
- Systemic chemotherapy for any cancer
- Pregnant or lactating
- Contraindication to breast MRI with contrast enhancement
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and Specificity (co-primary)
Time Frame: 1 year
|
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer detection rate (CDR)
Time Frame: 1 year
|
To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography
|
1 year
|
Positive predictive value (PPV)
Time Frame: 1 year
|
To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography
|
1 year
|
Negative predictive value (NPV)
Time Frame: 1 year
|
To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography
|
1 year
|
Histopathologic characteristics of secondary breast cancers
Time Frame: 1 year
|
To describe the histologic type, tumor grade, and molecular tumor subtype of secondary breast cancers detected at AB-MR, US, and mammography
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Woo Kyung Moon, MD, PhD, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB-MR for Second Breast Cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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