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Clinical Trials/TCTR20201105004
TCTR20201105004
Not Yet Recruiting
N/A

Magnetic Resonance Elastography of Skeletal muscle in scleroderma with muscle involvement compared to Muscle biopsy: a pilot study

Faculty of medicine0 sites30 target enrollmentNovember 5, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
&#45
Sponsor
Faculty of medicine
Enrollment
30
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 5, 2020
End Date
January 31, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Faculty of medicine

Eligibility Criteria

Inclusion Criteria

  • 1\.Systemic sclerosis, age \>/\= 18 years old
  • 2\.Abnormal increased CPK enzyme level above upper normal limited (\> 200 IU/L).
  • 3\.Muscle weakness ≤grade IV based on manual muscle testing.

Exclusion Criteria

  • 1\.Deny performing muscle biopsy.
  • 2\.Ongoing immunosuppressive drug and unable to stop the drug due to prevent disease control flare up during the time of MRE examination (low dose steroid equivalent with prednisolone ≤15 mg/d is allow during MRE examination)
  • 3\.Having contraindication to perform muscle biopsy
  • 4\.Underlying bleeding disorder or coagulopathy
  • 5\.Take any anticoagulant, antiplatelet, or other medicines that affect blood clotting
  • 6\.Infection of the biopsy site
  • 7\.Absolute contraindication to perform MRI and MRE.
  • 8\.Pregnancy or lactation
  • 9\.Advanced stage of cancer

Outcomes

Primary Outcomes

Not specified

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