Ultrasound in Muscle Biopsy - Full Text View

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 Blind (Outcomes Assessor)
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: Biopsy Ultrasound

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

U.S. FDA Resources

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


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

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


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01790178 History of Changes
Other Study ID Numbers:	Pro00041999
Study First Received:	February 11, 2013
Results First Received:	August 1, 2016
Last Updated:	November 14, 2016

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 22, 2017