Histology of Functional Density in Premenopausal Breast
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-000458
NCT ID: NCT01588834
Sponsor Protocol Number: 12-000458
About this study
The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Ages 40 - 55 years
- Considered premenopausal or peri-menopausal
- Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
- No proliferative benign lesions (e.g. fibroadenomas) identified
- Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
- MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
- No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
- Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)
Exclusion criteria:
- Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
- Prior diagnosis of bilateral breast cancer.
- Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
- Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
- Current breast symptoms
- Breast implants
- Known allergy to local anesthetic.
- History of bleeding complications from prior interventions
- Current use of anticoagulants (e.g., Coumadin or other blood thinners)
- Major medical condition
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Carrie Hruska, Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available