Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona

Study Overview
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Brief Summary
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The overall objective of this clinical study is to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. These evaluations will help support follow-up clinical research utilizing breast density acquired by breast CT as a surrogate endpoint biomarker to evaluate breast cancer preventive strategies. The long-term goal of these research efforts is to develop safe and effective preventive strategies to reduce obesity-associated breast cancer burden in our catchment area.

Official Title
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Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona

Conditions
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Metabolic Syndrome, Obesity Associated Disorder

Intervention / Treatment
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* Diagnostic Test: Breast CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with BMI of 25 kg/m2 or greater 40-65 years of age Must self-identify as Mexican-origin living in Southern Arizona Ability to understand and the willingness to sign a written informed consent document in English or Spanish Exclusion Criteria: Women who are pregnant or lactating Women who have undergone treatment of chemotherapy and/or radiation for any malignancies within the past 2 years, excluding non-melanoma skin cancer or cancer confined to organs with surgical removal as the only treatment Women who have breast implants Women who have used selective estrogen receptor modulators, aromatase inhibitors, and /or hormone replacement therapy within the past 12 months. Women who have undergone bilateral mastectomy Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker Women who are unable to tolerate study constraints, frail, or unable to cooperate Women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease Women who have received large number of diagnostic x-ray examinations of the horax for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br> | Diagnostic Test: Breast CT<br>* This is a cross-sectional clinical study to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. There is no intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of breast density | To determine the feasibility of applying a novel clinical prototype of breast CT to assess breast density on non-compressed breasts. Feasibility will be evaluated by the proportion of unmeasurable breast density within our study population utilizing computerized tomography (CT) scan. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the association between metabolic syndrome and breast CT-derived density measures. | To determine the association between metabolic syndrome and breast CT-derived density measures through comparison of CT-derived breast density measures between women with or without metabolic syndrome, characterized by having at least three components among abdominal obesity, high serum triglycerides, low high-density lipoprotein cholesterol, high serum glucose, and high blood pressure. | Two years | 
| Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome. | To compare the CT-derived breast density measures versus the individual components of metabolic syndrome to reveal associations between breast density and specific metabolic characteristics. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast density, Breast CT, Mexican-origin Women, Breast Cancer Prevention, Metabolic Syndrome, Obesity- Associated Breast Cancer