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

NCT ID: NCT04799665

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2024-05-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Breast CT

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherry Chow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

2012285106

Identifier Type: -

Identifier Source: org_study_id