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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy|
- 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.
- 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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Ultrasound Guided Biopsy
Ultrasound guided biopsy will be used in all patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790178
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Lisa D. Hobson-Webb, MD||Duke University|