Status:
COMPLETED
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
Lead Sponsor:
University of Arizona
Conditions:
Metabolic Syndrome
Obesity Associated Disorder
Eligibility:
FEMALE
40-65 years
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 overwe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04799665
Start Date
April 28 2022
End Date
May 1 2024
Last Update
May 21 2024
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724