Could new scans and duct wash detect breast cancer earlier in High-Risk women?
NCT ID NCT00006421
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 13 times
Summary
This study tested new screening methods like MRI, duct lavage, and PET scans in 200 women with BRCA gene mutations who are at high risk for breast cancer. The goal was to see if these tools can find cancer earlier than standard mammograms. Participants were followed for three years with annual exams and imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 2-Fluorodeoxyglucose
- What this could lead to
- If successful, this could lead to better early detection methods for breast cancer in high-risk women, potentially improving survival rates.
- What could go wrong
- This is an observational study focused on screening methods, not a treatment trial. It may not directly improve outcomes, and the small sample size limits generalizability.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
200 people
The number who actually took part.
- Started
-
Oct 2000
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriers /non-carriers using two imaging modalities: mammography and MRI. This is a prospective cohort study of 200 women to gather data on the evolution of epithelial cell/molecular changes in BRCA1/2 mutation carriers, by collecting/analyzing NAF, BDL fluid, biopsy tissues (when indicated), and serum/lymphocytes; samples are stored for future studies. Eligible study participants include: 1)Women 25-56 years of age carrying a known deleterious mutation; 2) BRCA1/2@@@Women between the ages of 25 56 who are first- or second- degree relatives of individuals with a deleterious mutation. BRCA1/2, and 3)Women aged 25-56 who are first- or second- degree relatives of individuals with associated cancers in families with documented BRCA- BRCA mutations.
- Ages
-
18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA - Annual Follow-up Study: To participate in the Annual Follow-up Study, a woman must: Be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 56 years of age. Must be: A known BRCA1 or BRCA2 deleterious mutation carrier OR A first- or second- degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation OR A first- or second- degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation. Have undergone genetic counseling and risk assessment. Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making. Have an ECOG performance status of 0-1. Be able to provide informed consent. Have at least one non-irradiated breast. EXCLUSION CRITERIA - Annual Follow-up Study: Any of the following will result in exclusion from the Annual Follow-up Study: Pregnancy or lactation within 6 months of enrollment. Abnormal CA-125 level. Bilateral breast cancer, ovarian (any stage) or breast cancer (Stage IIB or worse) unless relapse free for 5 years prior to the time of enrollment. Patients with DCIS, Stage I and Stage II breast cancer are eligible provided that it has been at least 6 months from the completion of primary therapy (surgery, radiation, and chemotherapy as applicable). Tamoxifen and aromatase inhibitor adjuvant therapy is allowed. Patients with DCIS, Stage I and Stage II breast cancer who have had a local relapse after primary treatment are not eligible unless they have been relapse free for 5 years prior to the time of enrollment. History of other invasive cancer unless relapse free for 5 years prior to the time of enrollment. Non-Melanoma skin cancer or cervical carcinoma in situ are excepted. Previous bilateral mastectomy or bilateral radiation therapy. Weigh over 136 kilograms. Allergy to gadolinium. Allergy to lidocaine or Marcaine (bupivacaine). (excluded from breast duct lavage only). Subareolar or other surgery of the breast to be studied which might disrupt the ductal systems. For example, papilloma resection, biopsy or fine needle aspirations (FNAs) within 2 cm of the nipple might disrupt the ductal systems. Biopsies or FNAs greater than 2 cm from the nipple are acceptable. (Excluded from ductal lavage only) A breast implant or prior silicone injections in the breast to be studied. (Exclude from breast ductal lavage only) Active infections or inflammation in a breast to be studied. (breast ductal lavage only) Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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