Clinical trial NCT04799665: Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
Official title: Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Obesity Associated Disorder
Keywords: Breast density
Breast CT
Mexican-origin Women
Breast Cancer Prevention
Metabolic Syndrome
Obesity- Associated Breast Cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 92
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight/obese Mexican-origin women in Southern Arizona.

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.


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.

Primary outcomes:
measure: Measurement of breast density
timeFrame: Baseline
Secondary outcomes:
measure: Determine the association between metabolic syndrome and breast CT-derived density measures.
timeFrame: Two years
measure: Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome.
timeFrame: Two years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Sherry Chow, PhD
role: PRINCIPAL_INVESTIGATOR
References: