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

NCT04799665 | Completed DMC

• 1 other identifier: 2012285106
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Obesity Associated Disorder

Keywords

Breast density; Breast CT; Mexican-origin Women; Breast Cancer Prevention; Metabolic Syndrome; Obesity- Associated Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

All Participants

Diagnostic Test: Breast CT

Interventions

Breast CT DIAGNOSTIC_TEST

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.

All Participants

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Overweight/obese Mexican-origin women in Southern Arizona.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Overweight/obese Mexican-origin women in Southern Arizona.

You may qualify if:

• Women with BMI of 25 kg/m2 or greater
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sherry Chow, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: April 28, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)