Clinical trial NCT01240278: Histology of Functional Density in Postmenopausal Breast
Official title: Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dense Breasts
Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.

Brief 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.


Eligibility 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

Primary outcomes:
measure: proportion of epithelium vs stroma
timeFrame: within 1 month of functional density assessment on MBI
Secondary outcomes:
measure: Degree of lobular involution
timeFrame: within 1 month of functional density assessment on MBI
measure: Ki-67 cellular proliferation index
timeFrame: within 1 month of functional density assessment on MBI
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carrie Hruska, PhD
role: PRINCIPAL_INVESTIGATOR
References: