The ULTRA Study: Cross-Comparison of Ultrasound Systems

Healthy Clinical Trial

— ULTRA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02920619
• Other study ID #: MIRB01803
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Ultrasound
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.

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Harris-Love MO, Seamon BA, Teixeira C, Ismail C. Ultrasound estimates of muscle quality in older adults: reliability and comparison of Photoshop and ImageJ for the grayscale analysis of muscle echogenicity. PeerJ. 2016 Feb 22;4:e1721. doi: 10.7717/peerj.1721. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echogenicity	Echogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)	1 day
Secondary	Muscle thickness	Morphometry values (units: cm) obtained from the ultrasound scans using digital calipers.	1 day