Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

Not yet recruiting

• Conditions: Myositis; Congenital Myopathy; Acquired Myopathy

• Registration Number: NCT05692349
• Lead Sponsor: Assiut University

Brief Summary

This study aims to determine the association between the pathological changes detected by ultrasound and those detected in MRI in muscle diseases of different etiologies.

Detailed Description

Enrolled patients will be subjected to the following:

Neuro-imaging Studies:

1. Skeletal Muscle ultrasound:

The muscle group(s) to be assessed will be determined based on the category of the muscle disease for which the patient is being evaluated. A linear probe of 5-12 megahertz will be used.

2. MRI of the suspected (affected) muscle group by ultrasound. Image acquisition: Selective regional MRI imaging will be done based on the results of muscle ultrasound MRI cuts included are the axial section of conventional T1- and T2-weighted sequences, for the evaluation of muscles' signal intensity and bulk.

Patients will be subjected to both imaging studies to compare their accuracy.

Neurophysiological Studies:

1. Nerve conduction study

2. Electromyogram The interpretation of the neurophysiological studies will be performed by a neuropsychiatry specialist, Department of Neurology, Assiut University Hospital.

Study Timeline

• Study First Submitted: 2022-07-22
• Status Verified: 2023-01
• Study Start: 2023-01
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-09
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. A clinical diagnosis of muscle diseases; irrespective of different etiologies
2. Age > 3 years

Exclusion Criteria

1. Patients with altered muscle anatomy due to severe trauma, tumor or surgery.
2. Severe deformity preventing examination.
3. Age < 3years.
4. Patients with contraindications to MRI as patients with pacemaker, aneurysmal clipping, retained metallic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of abnormal ultrasound and Magnetic resonance studies separately	through study completion, an average of 1 year	Abnormal Magnetic resonance study: muscle fat replacement (qualitatively through T1 weighted images, and qualitatively through Mercuric visual grading system), edema ( T2 relaxation time mapping), fibrosis ( magnetic resonance elastography) Abnormal muscle ultrasound study (replacement of healthy muscle with fat and fibrosis, manifested by an increase in echogenicity, visual method based on evaluating echogenicity in relation to other structures and semi-quantitatively)
Association between the results of Skeletal muscle ultrasound (normal vs. abnormal) and the results of MRI (normal vs. abnormal study)	within 6 months after recruitment ends (Recruitment completion is anticipated In Sep 2023)
Association between the individual abnormalities detected by skeletal muscle ultrasound and those detected by MRI.	within 6 months after recruitment ends (Recruitment completion is anticipated In Sep 2023)
Diagnostic accuracy of each modality in reference to the clinical and neurophysiological diagnosis and muscle biopsy.	within 6 months after recruitment ends (Recruitment completion is anticipated In Sep 2023)