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Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women


Phase 3
40 Years
55 Years
Open (Enrolling by invite only)
Female
Dense Breasts, Breast Cancer

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Trial Information

Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women


The specific aims are:

- In women with increased mammographic density (MD), determine the histological
characteristics of functionally dense tissue compared to that of non-functionally dense
tissue via core-needle biopsy of the breast.

- In women with increased mammographic density (MD), determine the correlations between
the total percent area of functional density (FD) on MBI, percent density of MD on
mammogram, and histological characteristics of dense tissue


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

proportion of epithelium vs stroma

Outcome Time Frame:

within 3 days of functional density assessment on MBI

Safety Issue:

No

Principal Investigator

Carrie B Hruska, PhD R-D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-000458

NCT ID:

NCT01588834

Start Date:

April 2012

Completion Date:

October 2014

Related Keywords:

  • Dense Breasts
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905