Ultrasound in Muscle Biopsy

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy

Conditions
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Myopathy, Myositis, Muscular Dystrophy

Intervention / Treatment
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* Procedure: Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Biopsy<br>Ultrasound guided biopsy will be used in all patients. | Procedure: Ultrasound<br>* The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.<br>|
| No Intervention: Non-Ultrasound Guided Group<br>The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Related to Muscle Biopsy | Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies. | Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy | 
| Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue | 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. | At time of biopsy | 
| Number of Participants With Inadequate Biopsy Samples | 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. | At time of pathology review |