Congenital MyopathyNCT05692349
Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases
An observational study of Congenital Myopathy and Acquired Myopathy, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Congenital Myopathy, Acquired Myopathy, Myositis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Muscle Disease of different aetiologies
Who may be able to join
- A clinical diagnosis of muscle diseases; irrespective of different etiologies
- Age > 3 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases
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.
Read the detailed description
Enrolled patients will be subjected to the following:
Neuro-imaging Studies:
- 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.
- 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:
- Nerve conduction study
- Electromyogram The interpretation of the neurophysiological studies will be performed by a neuropsychiatry specialist, Department of Neurology, Assiut University Hospital.
- Conditions
- Congenital Myopathy, Acquired Myopathy, Myositis
- Being tested
- MRI
- Keywords
- Muscle disease
- Medical subject headings
- Myotonia Congenita, Myositis, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Muscle Ultrasound, Muscle Biopsy, Neurophysiology (nerve conduction and EMG)
MRI will be employed to assess muscle composition, evidence of degeneration or replacement by fat
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: within 6 months after recruitment ends (Recruitment completion is anticipated In Sep 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital MyopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayseer Mohamed Hashem Hamza, Assiut University
- Investigators
- Eman A. E. Ahmed, Professor, Study chair, Assiut UniversitySara M. Ahmed, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692349
- Sponsor's protocol ID
- MRI and US in Muscle Disease
- Status last verified
- Jan 2023
- First submitted
- 22 Jul 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32495452Paoletti 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.
PubMed 30804884Bugiardini 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.
PubMed 29997562Smitaman 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.
PubMed 29451848Heckmatt 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.
PubMed 6104175Wijntjes 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.
PubMed 33051891Albayda 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.
PubMed 32989482Habers 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.
PubMed 25557638Pillen 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.
PubMed 16967365
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases
- ClinicalTrials.gov ID
- NCT05692349
- Acronym / sponsor ID
- MRI and US in Muscle Disease
- Conditions
- Congenital Myopathy, Acquired Myopathy, Myositis
- Keywords
- Muscle disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Nerve conduction study
- Electromyogram The interpretation of the neurophysiological studies will be performed by a neuropsychiatry specialist, Department of Neurology, Assiut University Hospital.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Muscle Disease of different aetiologies
Key inclusion criteria (2 listed)
- A clinical diagnosis of muscle diseases; irrespective of different etiologies
- Age > 3 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Muscle Ultrasound, Muscle Biopsy, Neurophysiology (nerve conduction and EMG)MRI will be employed to assess muscle composition, evidence of degeneration or replacement by fat | Device | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 32495452Dahlqvist 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.
- Background: PubMed 30804884Paoletti 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.
- Background: PubMed 29997562Bugiardini 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.
- Background: PubMed 29451848Smitaman 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.
- Background: PubMed 6104175Heckmatt 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.
- Background: PubMed 33051891Wijntjes 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.
- Background: PubMed 32989482Albayda 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.
- Background: PubMed 25557638Habers 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.
- Background: PubMed 16967365Pillen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman A. E. Ahmed, Professor study chair
Assiut University
Sara M. Ahmed, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Myopathy and Acquired Myopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayseer MH Hamza, resident (01097633005, tayseerhashem7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of abnormal ultrasound and Magnetic resonance studies separately (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692349, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.