Clinical trial NCT01588834: Histology of Functional Density in Premenopausal Breast
Official title: Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dense Breasts
Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: 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: 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.

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 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

Primary outcomes:
measure: proportion of epithelium vs stroma
timeFrame: within 3 days of functional density assessment on MBI
Secondary outcomes:
measure: Degree of lobular involution
timeFrame: within 3 days of functional density assessment on MBI
measure: Ki-67 cellular proliferation index
timeFrame: within 3 days of functional density assessment on MBI
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carrie B Hruska, PhD R-D
role: PRINCIPAL_INVESTIGATOR
References: