Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Measurement of breast density
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Measurement of breast density
时间窗: Baseline
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.
次要结局
- Determine the association between metabolic syndrome and breast CT-derived density measures.(Two years)
- Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome.(Two years)