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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Obesity Associated Disorder
• Intervention / Treatment: Diagnostic test: Breast CT

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Amy Selegue, BA, BSN, MLS; Phone Number: 520-318-9298; Email: aselegue@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
      • Contact: Amy Selegue, BA, BSN, MLS; Phone Number: 520-626-0301; Email: aselegue@arizona.edu
      • Principal Investigator: Sherry Chow, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Overweight/obese Mexican-origin women in Southern Arizona.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Sherry Chow, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Anticipated): April 28, 2024
• Study Completion (Anticipated): April 28, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Breast Cancer Prevention; Breast CT; Breast density; Mexican-origin Women; Obesity- Associated Breast Cancer
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 2012285106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No