NCT04799665Completed
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
Source: ClinicalTrials.gov · Last updated 21 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 92 (actual)
- First submitted
- 11 Mar 2021
- Start date
- 28 Apr 2022
- Primary completion date
- 1 May 2024
- Lead sponsor
- University of Arizona
- Diseases
- Obesity
- NCT number
- NCT04799665
What you commit to
- Study type: Observational
- Participants enrolled: 92
- From 28 Apr 2022 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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 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.
Other illness
- 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 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
Other
- Women who are pregnant or lactating
- Women who have undergone bilateral mastectomy
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.