Histology of Functional Density in Premenopausal Breast

Overview

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

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions