Histology of Functional Density in Premenopausal Breast

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01588834
First received: April 26, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Dense Breasts
Breast Cancer
Procedure: breast biopsy
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • proportion of epithelium vs stroma [ Time Frame: within 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of lobular involution [ Time Frame: within 3 days 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 3 days 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.


Biospecimen Retention:   Samples Without DNA

core biopsy samples from mammographically dense breast tissue


Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breast biopsy
    ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
Detailed Description:

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
  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588834

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

Additional Information:
No publications provided

Responsible Party: Carrie Hruska, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01588834     History of Changes
Other Study ID Numbers: 12-000458
Study First Received: April 26, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014