Ultrasound in Muscle Biopsy

Muscular Dystrophy Clinical Trial

Official title:

Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790178
• Other study ID #: Pro00041999
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: January 19, 2016
• Start date: February 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.

Exclusion Criteria:

• Age under 18 years.

• Inability to provide consent for participation.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy
• Myopathy
• Myositis

Intervention

Procedure:
• Ultrasound
The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Tissue Obtained by Ultrasound Guided Muscle Biopsies	This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).	10 months	No
Primary	Diagnostic Yield of Ultrasound Guided Muscle Biopsies	The rate of achieving a final diagnosis in ultrasound guided muscle biopsies vs. unguided muscle biopsies will be examined.	10 months	No
Secondary	Improving the Safety of Core/Needle Muscle Biopsies	Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.	10 months	Yes