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

History of Changes

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:

Genetics Home Reference related topics: idiopathic inflammatory myopathy

MedlinePlus related topics: Muscular Dystrophy Ultrasound

Genetic and Rare Diseases Information Center resources: Idiopathic Myopathy Muscular Dystrophy

U.S. FDA Resources

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 Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic	Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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