Metabolic SyndromeNCT04799665
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
An observational study of Metabolic Syndrome and Obesity Associated Disorder, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity Associated Disorder
- What is being tested?
- Breast CT
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Overweight/obese Mexican-origin women in Southern Arizona.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Breast CT
- Keywords
- Breast density, Breast CT, Mexican-origin Women, Breast Cancer Prevention, Metabolic Syndrome, Obesity- Associated Breast Cancer
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Diagnostic Test: Breast CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Determine the association between metabolic syndrome and breast CT-derived density measures.
To determine the association between metabolic syndrome and breast CT-derived density measures through comparison of CT-derived breast density measures between women with or without metabolic syndrome, characterized by having at least three components among abdominal obesity, high serum triglycerides, low high-density lipoprotein cholesterol, high serum glucose, and high blood pressure.
Measured: Two years
Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome.
To compare the CT-derived breast density measures versus the individual components of metabolic syndrome to reveal associations between breast density and specific metabolic characteristics.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start28 Apr 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherry Chow, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799665
- Sponsor's protocol ID
- 2012285106
- Status last verified
- May 2024
- First submitted
- 11 Mar 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
- ClinicalTrials.gov ID
- NCT04799665
- Acronym / sponsor ID
- 2012285106
- Conditions
- Metabolic Syndrome, Obesity Associated Disorder
- Keywords
- Breast density, Breast CT, Mexican-origin Women, Breast Cancer Prevention, Metabolic Syndrome, Obesity- Associated Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Breast CT |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight/obese Mexican-origin women in Southern Arizona.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast CTThis 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. | Diagnostic test | All Participants |
Primary outcome
Measurement of breast density
Time frame: Baseline
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.
2 secondary outcomes
Determine the association between metabolic syndrome and breast CT-derived density measures.
Time frame: Two years
Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Chow, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Obesity Associated Disorder, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of breast density (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.