Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

January 18, 2023 updated by: Tayseer Mohamed Hashem Hamza, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Muscle Disease of different aetiologies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Eman A. E. Ahmed, Professor, Assiut University
  • Study Director: Sara M. Ahmed, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI and US in Muscle Disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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