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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799665
• Other study ID #: 2012285106
• Status: Recruiting
• Start date: April 28, 2022
• Est. completion date: April 28, 2024

Study information

• Verified date: May 2023
• Source: University of Arizona
• Contact: Amy Selegue, BA, BSN, MLS
• Phone: 520-318-9298
• Email: aselegue[@]arizona.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity Associated Disorder

Intervention

Diagnostic Test:
• Breast CT
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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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