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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01240278
Other study ID # 10-004506
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 2010
Est. completion date December 2018

Study information

Verified date October 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of epithelium vs stroma within 1 month of functional density assessment on MBI
Secondary 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. within 1 month of functional density assessment on MBI
Secondary 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. within 1 month of functional density assessment on MBI
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