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Clinical Trials/NCT05692349
NCT05692349
Not yet recruiting
Not Applicable

Role of Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

Assiut University0 sites36 target enrollmentJanuary 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Myopathy
Sponsor
Assiut University
Enrollment
36
Primary Endpoint
Percentage of abnormal ultrasound and Magnetic resonance studies separately
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2023
End Date
January 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tayseer Mohamed Hashem Hamza

Resident doctor at assiut university

Assiut University

Eligibility Criteria

Inclusion Criteria

  • A clinical diagnosis of muscle diseases; irrespective of different etiologies
  • Age \> 3 years

Exclusion Criteria

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

Outcomes

Primary Outcomes

Percentage of abnormal ultrasound and Magnetic resonance studies separately

Time Frame: 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)

Time Frame: 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.

Time Frame: 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.

Time Frame: within 6 months after recruitment ends (Recruitment completion is anticipated In Sep 2023)

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