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Completed

NCT Number: NCT01790178

Ultrasound in Muscle Biopsy

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.

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Key information

Conditions

Myopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2013
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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