Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.

NCT05729880 | Completed

• 1 other identifier: 2021-22-44
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to see if ultrasound can be used as a reliable and valid method to measure fatty infiltration, muscle thickness and muscle architecture to provide a quick, cheap and mobile alternative measure of muscle quality to MRI. The MRS and MRI images will be used to validate the ultrasound images.

Conditions

Muscle Atrophy

Keywords

ultrasound; mri

Outcome Measures

Primary Outcomes (3)

• Ultrasound muscle thickness (cm)

  A single ultrasound image can measure both thickness (cm) and echogenecity (AU). Echogenecity has been used as a proxy for fat infiltration. By combining both thickness and fat infiltration and index of muscle quality can be determined

  1 year

• Ultrasound echogenecity (arbitrary units on histogram)

  A single ultrasound image can measure both thickness (cm) and echogenecity (AU). Echogenecity has been used as a proxy for fat infiltration. By combining both thickness and fat infiltration and index of muscle quality can be determined

  1 year

• Fat fraction

  Obtained from MRI and will be used to validate the ultrasound echogenecity

  1 year

Study Arms (2)

Older

16 older (\>50y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.

Diagnostic Test: MRI, MRS; Diagnostic Test: Ultrasound

Young

16 young (\<40y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.

Diagnostic Test: MRI, MRS; Diagnostic Test: Ultrasound

Interventions

MRI, MRS DIAGNOSTIC_TEST

Scan of right calf and thigh

Older; Young

Ultrasound DIAGNOSTIC_TEST

Scan of right calf and thigh

Older; Young

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may qualify if:

• \- Age \<40y or \>50yrs

You may not qualify if:

• Significant cognitive deficits and the inability to follow directions during assessment.
• Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
• Prosthesis with metalwork, eg. metal work from surgery
• Aneurysm clip in situ
• No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
• Previous exposure to metal flakes and metallic injury.
• No external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices.
• Non-removal hearing aids
• FEMALE ONLY Not pregnant
• Not claustrophobic

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University

Exeter, Devon, EX2 4TH, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Magnetic Resonance Imaging; Positron-Emission Tomography; Ultrasonography

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Francis Stephens

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 15, 2023
• Study Start: June 10, 2022
• Primary Completion: November 16, 2022
• Study Completion: April 1, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)