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PURPOSE: Screening study of MRI and PET to detect cancer in women who have a genetic risk for breast cancer.
- Determine whether breast imaging outcome measures can be used to define a high-risk imaging phenotype in women who are BRCA1 or BRCA2 mutation carriers or non-carriers.
- Assess the use of positron emission tomography imaging of breast lesions detected by mammography or magnetic resonance imaging, normal contralateral breast tissue, and normal ovarian tissue in BRCA1/2 carriers or non-carriers.
- Assess the use of breast duct lavage to obtain epithelial cell samples for cytologic evaluation and molecular/genetic studies in high-risk premenopausal women.
- Compare imaging findings with histologic or cytologic findings from these participants.
- Determine the psychosocial impact of participation in an intensive breast cancer screening program on these participants.
- Assess prior breast cancer screening practices in these participants.
- Determine participant burden (distress, pain, and/or discomfort) in regards to specific procedures used in the course of the study (breast duct lavage, nipple aspiration, mammography, and breast MRI).
- Determine participants perceptions of uncertainty and its determinants regarding the results of their cancer screening tests.
- Determine the effect of a positive BRCA mutation test result on participants attitudes and intentions regarding the formation and maintenance of permanent couple relationships.
OUTLINE: Participants undergo a physical exam, including exam of breast and pelvis, standard four-view mammogram, breast magnetic resonance imaging (MRI), CA 125 level determination, and transvaginal color doppler ultrasonography. Participants with abnormal mammogram and/or MRI results are asked to undergo positron emission tomography scans of the breast and asymptomatic ovaries. Breast duct lavage fluid is collected from all participants for cytologic analysis. Participants undergo repeat screening studies annually for 3 years.
Participants are followed annually.
PROJECTED ACCRUAL: Approximately 200 participants (100 BRCA1/2 mutation carriers and 100 BRCA1/2 mutation non-carriers) will be accrued for this study.
Primary Purpose: Screening
brca1 Mutation Carrier
cytogenetic analysis, cytology specimen collection procedure, breast duct lavage, breast imaging study, magnetic resonance imaging, mutation carrier screening, positron emission tomography, radiomammography, ultrasound imaging
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:35:08-0400
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