Ultrasound in Muscle Biopsy

Not Applicable

Completed

• Conditions: Muscular Dystrophy; Myopathy; Myositis
• Interventions: Procedure: Ultrasound

• Registration Number: NCT01790178
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-08-01
• Results First Submitted QC: 2016-09-26
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Results First Posted: 2016-11-15
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• Age under 18 years.
• Inability to provide consent for participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Biopsy	Ultrasound	Ultrasound guided biopsy will be used in all patients.

Primary Outcome Measures

Name	Time	Method
Amount of Tissue Obtained	At time of biopsy	This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).
Number of Patients Receiving Diagnosis From Muscle Biopsy	At time of biopsy	The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Related to Muscle Biopsy	Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy	Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.
Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue	At time of biopsy	For "core" or "needle" biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm.
Number of Participants With Inadequate Biopsy Samples	At time of pathology review	The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States