- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920619
The ULTRA Study: Cross-Comparison of Ultrasound Systems (ULTRA)
May 16, 2018 updated by: Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
The ULTRA Study: Cross-Comparison of Muscle Composition Measures in Multiple Ultrasound Systems
The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.
Study Overview
Detailed Description
The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.
We propose a cross-sectional study to obtain ultrasound images of selected muscles in Veteran participants.
These data will be used to develop conversion models for each system.
Evaluation of neuromuscular symptoms such as muscle weakness and fatigue is crucial to improving quality of life among Veterans.
These symptoms may be related to progressive changes in muscle tissue composition, including increased intramuscular fat and atrophy.
Quantitative musculoskeletal ultrasound is a diagnostic imaging application used to characterize muscle tissue composition.
Despite its non-invasiveness and relative low cost, quantitative musculoskeletal ultrasound has not been widely adopted by the medical community due in part to technical barriers that impede generalization of measurements across ultrasound systems.
Unfortunately, few techniques have been proposed to reliably compare system measurements.
Development of new cross-comparison methods could expand quantitative musculoskeletal ultrasound applications and improve neuromuscular symptoms diagnosis.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20422
- Washington DC VA medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Thirty adult Veterans (20-85 years) will be recruited for the study from the DC VAMC.
Description
Inclusion Criteria:
- Male or female Veteran who receives medical care at the Washington DC VA Medical Center
- Ages 20-85
Exclusion Criteria:
- Limb amputation (upper or lower extremity)
- Lower extremity joint replacement
- Severe cognitive impairment
- Edema
- Inability to read, speak, or understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Echogenicity
Time Frame: 1 day
|
Echogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle thickness
Time Frame: 1 day
|
Morphometry values (units: cm) obtained from the ultrasound scans using digital calipers.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Harris-Love, D.Sc., Washington DC VA medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 24, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Actual)
May 17, 2018
Last Update Submitted That Met QC Criteria
May 16, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MIRB01803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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