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Histology of Functional Density in Postmenopausal Breast

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01240278
First received: November 5, 2010
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.


Condition Intervention
Dense Breasts
Breast Cancer
 Procedure: breast biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • proportion of epithelium vs stroma [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of lobular involution [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
    Degree of lobular involution as assessed through qualitative and quantitative measurements will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.

  • Ki-67 cellular proliferation index [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
    Degree of cellular proliferation as assessed through Ki-67 index will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breast biopsy
    ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240278

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Carrie Hruska, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Carrie Hruska, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01240278     History of Changes
Other Study ID Numbers: 10-004506
Study First Received: November 5, 2010
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013