Ultrasound in Muscle Biopsy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01790178
First received: February 11, 2013
Last updated: March 3, 2014
Last verified: March 2014
  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: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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 by Ultrasound Guided Muscle Biopsies [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).

  • Diagnostic Yield of Ultrasound Guided Muscle Biopsies [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    The rate of achieving a final diagnosis in ultrasound guided muscle biopsies vs. unguided muscle biopsies will be examined.


Secondary Outcome Measures:
  • Improving the Safety of Core/Needle Muscle Biopsies [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Non-Ultrasound Guided Group
The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients referred to the Duke EMG Laboratory for core (needle) muscle biopsies.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01790178     History of Changes
Other Study ID Numbers: Pro00041999
Study First Received: February 11, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014