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Imaging Procedures in Women With a Genetic Risk For Breast Cancer

2014-07-24 14:35:08 | BioPortfolio

Summary

RATIONALE: Imaging procedures, such as MRI and PET scans, may improve the ability to detect cancer in women who have a genetic risk for breast cancer.

PURPOSE: Screening study of MRI and PET to detect cancer in women who have a genetic risk for breast cancer.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Design

Primary Purpose: Screening

Conditions

brca1 Mutation Carrier

Intervention

cytogenetic analysis, cytology specimen collection procedure, breast duct lavage, breast imaging study, magnetic resonance imaging, mutation carrier screening, positron emission tomography, radiomammography, ultrasound imaging

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:35:08-0400

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Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.

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