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Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women


N/A
40 Years
N/A
Open (Enrolling by invite only)
Female
Dense Breasts, Breast Cancer

Thank you

Trial Information

Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women


Inclusion Criteria:



1. Age 40 or older

2. Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea

3. Screening mammogram performed at Mayo Clinic Rochester within one year prior to the
current MBI study which demonstrates

1. Negative or benign assessment (BIRADs category 1-2)

2. No proliferative benign lesions (e.g. fibroadenomas) identified

3. Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3
or 4)

4. MBI performed less than one month prior to biopsy demonstrating either significant FD
or photopenic FD.

Exclusion criteria:

1. Using any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones) or
any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase
inhibitors within six months prior to study biopsy.

2. Personal history of any cancer, except non-melanomatous skin cancer

3. Current breast symptoms

4. Breast implants

5. Known allergy to local anesthetic.

6. History of bleeding complications from prior interventions

7. Current use of anticoagulants (e.g., Coumadin or other blood thinners)

8. 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 1 month of functional density assessment on MBI

Safety Issue:

No

Principal Investigator

Carrie Hruska, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

10-004506

NCT ID:

NCT01240278

Start Date:

November 2010

Completion Date:

December 2014

Related Keywords:

  • Dense Breasts
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic in RochesterRochester, Minnesota  55905