Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05692349
• Other study ID #: MRI and US in Muscle Disease
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Tayseer MH Hamza, resident
• Phone: 01097633005
• Email: tayseerhashem7[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Myopathy
• Muscular Diseases
• Myositis

Intervention

Device:
• MRI
MRI will be employed to assess muscle composition, evidence of degeneration or replacement by fat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Albayda J, van Alfen N. Diagnostic Value of Muscle Ultrasound for Myopathies and Myositis. Curr Rheumatol Rep. 2020 Sep 28;22(11):82. doi: 10.1007/s11926-020-00947-y. — View Citation

Bugiardini E, Morrow JM, Shah S, Wood CL, Lynch DS, Pitmann AM, Reilly MM, Houlden H, Matthews E, Parton M, Hanna MG, Straub V, Yousry TA. The Diagnostic Value of MRI Pattern Recognition in Distal Myopathies. Front Neurol. 2018 Jun 26;9:456. doi: 10.3389/fneur.2018.00456. eCollection 2018. — View Citation

Dahlqvist JR, Widholm P, Leinhard OD, Vissing J. MRI in Neuromuscular Diseases: An Emerging Diagnostic Tool and Biomarker for Prognosis and Efficacy. Ann Neurol. 2020 Oct;88(4):669-681. doi: 10.1002/ana.25804. Epub 2020 Jul 1. — View Citation

Habers GE, Van Brussel M, Bhansing KJ, Hoppenreijs EP, Janssen AJ, Van Royen-Kerkhof A, Pillen S. Quantitative muscle ultrasonography in the follow-up of juvenile dermatomyositis. Muscle Nerve. 2015 Oct;52(4):540-6. doi: 10.1002/mus.24564. Epub 2015 Mar 14. — View Citation

Heckmatt JZ, Dubowitz V, Leeman S. Detection of pathological change in dystrophic muscle with B-scan ultrasound imaging. Lancet. 1980 Jun 28;1(8183):1389-90. doi: 10.1016/s0140-6736(80)92656-2. — View Citation

Paoletti M, Pichiecchio A, Cotti Piccinelli S, Tasca G, Berardinelli AL, Padovani A, Filosto M. Advances in Quantitative Imaging of Genetic and Acquired Myopathies: Clinical Applications and Perspectives. Front Neurol. 2019 Feb 11;10:78. doi: 10.3389/fneur.2019.00078. eCollection 2019. — View Citation

Pillen S, Morava E, Van Keimpema M, Ter Laak HJ, De Vries MC, Rodenburg RJ, Zwarts MJ. Skeletal muscle ultrasonography in children with a dysfunction in the oxidative phosphorylation system. Neuropediatrics. 2006 Jun;37(3):142-7. doi: 10.1055/s-2006-924512. — View Citation

Smitaman E, Flores DV, Mejia Gomez C, Pathria MN. MR Imaging of Atraumatic Muscle Disorders. Radiographics. 2018 Mar-Apr;38(2):500-522. doi: 10.1148/rg.2017170112. Epub 2018 Feb 16. — View Citation

Wijntjes J, van Alfen N. Muscle ultrasound: Present state and future opportunities. Muscle Nerve. 2021 Apr;63(4):455-466. doi: 10.1002/mus.27081. Epub 2020 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of abnormal ultrasound and Magnetic resonance studies separately	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)	through study completion, an average of 1 year
Primary	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)
Primary	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)
Primary	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)