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The ULTRA Study: Cross-Comparison of Ultrasound Systems

The ULTRA Study: Cross-Comparison of Muscle Composition Measures in Multiple Ultrasound Systems

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02920619
Acronym
ULTRA
Enrollment
30
Registered
2016-09-30
Start date
2016-09-30
Completion date
2018-12-31
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ultrasound, muscle

Brief summary

The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.

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.

Interventions

DEVICEUltrasound

Imaging of the rectus femoris, lower-trapezius, brachioradialis, tibialis anterior, middle deltoid, and pectoralis major will be conducted in Veteran participants during a single visit to the Washington D.C. Veterans Affairs Medical Center. Imaging will be conducted by investigators experienced with quantitative ultrasound using diagnostic musculoskeletal B-mode ultrasound with a 10 Mhz linear transducer.

Sponsors

Washington D.C. Veterans Affairs Medical Center
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Echogenicity1 dayEchogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)

Secondary

MeasureTime frameDescription
Muscle thickness1 dayMorphometry values (units: cm) obtained from the ultrasound scans using digital calipers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026