Ultrasound in Muscle Biopsy

Duke University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Myopathy Myositis Muscular Dystrophy

Interventions

UltrasoundPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: At time of biopsy

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At time of pathology review

Data from ClinicalTrials.gov

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