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OpenTrials
Completed

NCT Number: NCT01588834

Histology of Functional Density in Premenopausal Breast

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.

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Key information

Age range

40 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breast biopsy

Procedure

ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue

Primary outcomes

  1. proportion of epithelium vs stroma

    Time frame: within 3 days of functional density assessment on MBI

Secondary outcomes

  1. Degree of lobular involution

    Time frame: within 3 days of functional density assessment on MBI

    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.

  2. Ki-67 cellular proliferation index

    Time frame: within 3 days of functional density assessment on MBI

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 1, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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