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

April 26, 2012
April 10, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
proportion of epithelium vs stroma [ Time Frame: within 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588834 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Histology of Functional Density in Premenopausal Breast
Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

core biopsy samples from mammographically dense breast tissue

Non-Probability Sample

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

  • Dense Breasts
  • Breast Cancer
Procedure: breast biopsy
ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
October 2015
April 2015   (final data collection date for primary outcome measure)

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
Female
40 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01588834
12-000458
Yes
Carrie Hruska, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Carrie B Hruska, PhD R-D Mayo Clinic
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP