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CompletedNCT01240278Updated Jul 26, 2022

Histology of Functional Density in Postmenopausal Breast

An observational study in Dense Breasts and Breast Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
40 Years and older
Sex
Female
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Study summary

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.

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Conditions studied

  • Dense Breasts
  • Breast Cancer
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In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. proportion of epithelium vs stroma

    Time frame: within 1 month of functional density assessment on MBI

Secondary outcomes

  1. Degree of lobular involution

    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.

    Time frame: within 1 month of functional density assessment on MBI

  2. Ki-67 cellular proliferation index

    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.

    Time frame: within 1 month of functional density assessment on MBI

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01240278
Lead sponsor
Mayo Clinic
Responsible party
Carrie Hruska (Professor, Mayo Clinic) — Principal investigator
First posted
Nov 15, 2010
Start date
Nov 2010
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022
Last update
Jul 26, 2022

Study contacts

Carrie Hruska, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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