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
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.
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.
Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.
Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
Exclusion criteria:
proportion of epithelium vs stroma
Time frame: within 1 month of functional density assessment on MBI
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
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
Plan to share: No
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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