NIH Clinical Center logo     America's Clinical Research Hospital File folder iconExplore the NIH
Clinical Center
Search the Studies - NIH Clinical Research Studies

Protocol Details

Breast Imaging Screening Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-up Study

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 18
MAX Age: 100

Referral Letter Required


Population Exclusion(s)


Special Instructions

Currently Not Provided


Breast MRI;
Nipple Aspirate Fluid;
Transvaginal ultrasound;
Ductal lavage

Recruitment Keyword(s)



Breast Cancer

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Cancer Institute

This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene.

Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or 99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study.

At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors, family and personal history of cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and previous surgery on the breasts and ovaries. In addition, they will undergo the following procedures:

Routine breast and ovarian cancer screening for high-risk women, including a mammogram, breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and transvaginal ultrasound of the ovaries.

Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues.

Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes.

Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation. This diagnostic test is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels.

Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above, blood draw, update of family history and risk factors, breast MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further evaluation, the PET will be repeated.

--Back to Top--


This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

--Back to Top--


Koehly LM, Peters JA, Kenen R, Hoskins LM, Ersig AL, Kuhn NR, Loud JT, Greene MH. Characteristics of health information gatherers, disseminators, and blockers within families at risk of hereditary cancer: implications for family health communication interventions. Am J Public Health. 2009 Dec;99(12):2203-9. doi: 10.2105/AJPH.2008.154096. Epub 2009 Oct 15.

Loud JT, Thi(SqrRoot)(Copyright)baut AC, Abati AD, Filie AC, Nichols K, Danforth D, Giusti R, Prindiville SA, Greene MH. Ductal lavage in women from BRCA1/2 families: is there a future for ductal lavage in women at increased genetic risk of breast cancer? Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1243-51. doi: 10.1158/1055-9965.EPI-08-0795. Epub 2009 Mar 31.

Gierach GL, Loud JT, Chow CK, Prindiville SA, Eng-Wong J, Soballe PW, Giambartolomei C, Mai PL, Galbo CE, Nichols K, Calzone KA, Vachon C, Gail MH, Greene MH. Mammographic density does not differ between unaffected BRCA1/2 mutation carriers and women at low-to-average risk of breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):245-55. doi: 10.1007/s10549-010-0749-7. Epub 2010 Feb 4.

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Jennifer T. Loud, C.R.N.P.
National Cancer Institute (NCI)
BG 9609 RM 6E536
(301) 594-7642

Jennifer T. Loud, C.R.N.P.
National Cancer Institute (NCI)
BG 9609 RM 6E536
(301) 594-7642

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Public View: 01-c-0009

Clinical Trials Number:


--Back to Top--


Contact the Patient Recruitment and Public Liaison Office for:

  • Details on how to participate in a study
  • Details on how to refer a patient to a study

NIH Clinical Studies Information Request

Contact the Office of Communications for:

  • General information about the NIH Clinical Center

Contact the Department Clinical Research Informatics, (DCRI) for:

  • Technical questions about Adobe Acrobat and the PDF format
  • Technical questions about this web server