Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Meets one of the following criteria: - Known carrier of BRCA1 or BRCA2 mutation - First- or second-degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation - First- or second-degree relative of an individual with a tumor associated with Breast-Ovarian Cancer Syndrome in a family with known BRCA mutation - Has undergone genetic counseling and risk assessment - No abnormal CA 125 level - No bilateral breast cancer, ovarian cancer (any stage), or stage IIB or greater breast cancer within the past 5 years - Ductal carcinoma in situ or stage I-IIA breast cancer allowed provided the following are true: - At least 6 months since completion of prior primary therapy (surgery, radiotherapy, and/or chemotherapy) - Tamoxifen or aromatase inhibitor adjuvant therapy allowed - No local relapse after prior primary treatment unless patient has been relapse free for 5 years before study entry - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 25 (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with Breast-Ovarian Cancer Syndrome) to 56 Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine ≤ 2 mg/dL Cardiovascular - No cardiac complications, including any of the following: - Myocardial infarction within the past year - Cerebrovascular accident within the past year - Unstable or uncontrolled angina - or Other: - Must agree to release results of genetic counseling for stratification purposes - Normal fasting blood glucose (for positron emission tomography [PET] study only) - Weight less than 136 kg (299 lbs) - Clinically stable to complete the full 3-month course of vaccination based on the opinion of the study investigator - No allergy to gadolinium, lidocaine, or bupivacaine - No history of diabetes (for PET study only) - No other invasive cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No medical or psychiatric disorder that would preclude study participation or giving informed consent - Not pregnant or nursing within the past 6 months - No active infection or inflammation of the breast being studied PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - No prior bilateral radiotherapy to the breasts Surgery: - See Disease Characteristics - No prior bilateral mastectomy or oophorectomy - No prior subareolar (e.g., papilloma resection or biopsy or fine needle aspiration within 2 cm of the nipple) or other surgery to the breast being studied which might have disrupted the ductal system (ductal lavage patients only) - No breast implants Other: - No prior silicone injection to the breast being studied


NCT ID:

NCT00012415


Primary Contact:

Principal Investigator
Jennifer Loud
Clinical Genetics Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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