Ultrasound in Muscle Biopsy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Myopathy; Myositis; Muscular Dystrophy	Procedure: Ultrasound	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Official Title:	Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy
Study Start Date :	February 2013
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Amount of Tissue Obtained [ Time Frame: 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).
2. Number of Patients Receiving Diagnosis From Muscle Biopsy [ Time Frame: 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 :

1. Number of Participants With Adverse Events Related to Muscle Biopsy [ Time Frame: 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.
2. Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue [ Time Frame: 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.
3. Number of Participants With Inadequate Biopsy Samples [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	Lisa D. Hobson-Webb, MD	Duke University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01790178 History of Changes
Other Study ID Numbers:	Pro00041999
First Posted:	February 13, 2013
Results First Posted:	November 15, 2016
Last Update Posted:	January 2, 2017
Last Verified:	November 2016

Additional relevant MeSH terms:

Muscular Dystrophies; Myositis; Muscular Disorders, Atrophic; Muscular Diseases	Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn