NCT05692349

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

July 22, 2022

Last Update Submit

January 18, 2023

Conditions

Congenital MyopathyAcquired MyopathyMyositis

Keywords

Muscle disease

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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)

Interventions

MRIDEVICE

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

Also known as: Muscle Ultrasound, Muscle Biopsy, Neurophysiology (nerve conduction and EMG)

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Muscle Disease of different aetiologies

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 32495452BACKGROUND

  • 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.

    PMID: 30804884BACKGROUND

  • 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.

    PMID: 29997562BACKGROUND

  • 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.

    PMID: 29451848BACKGROUND

  • 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.

    PMID: 6104175BACKGROUND

  • 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.

    PMID: 33051891BACKGROUND

  • 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.

    PMID: 32989482BACKGROUND

  • 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.

    PMID: 25557638BACKGROUND

  • 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.

    PMID: 16967365BACKGROUND

MeSH Terms

Conditions

Myotonia CongenitaMyositisMuscular Diseases

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Myotonic DisordersMusculoskeletal DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Eman A. E. Ahmed, Professor

    Assiut University

    STUDY CHAIR

  • Sara M. Ahmed, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Tayseer MH Hamza, resident

CONTACT

01097633005tayseerhashem7@gmail.com

Tayseer MH Hamza, resident

CONTACT

01099431433tweetyhashem@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at assiut university

Study Record Dates

First Submitted

July 22, 2022

First Posted

January 20, 2023

Study Start

January 1, 2023

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

January 20, 2023

Record last verified: 2023-01