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Ultrasound in Muscle Biopsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790178
First Posted: February 13, 2013
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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 Intervention
Myopathy Myositis Muscular Dystrophy Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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).

  • 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:
  • 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.

  • 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.

  • 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.


Enrollment: 40
Study Start Date: February 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790178


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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01790178     History of Changes
Other Study ID Numbers: Pro00041999
First Submitted: February 11, 2013
First Posted: February 13, 2013
Results First Submitted: August 1, 2016
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


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