Ultrasound in Muscle Biopsy

Outcomes of Ultrasound-guided Versus Blind Core 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 Overview

• Status: Completed
• Conditions: Muscular Dystrophy; Myositis; Myopathy
• Intervention / Treatment: Procedure: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Tissue Obtained	This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).	At time of biopsy
Number of Patients Receiving Diagnosis From Muscle Biopsy	The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.	At time of biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events Related to Muscle Biopsy	Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.	Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy
Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue	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.	At time of biopsy
Number of Participants With Inadequate Biopsy Samples	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.	At time of pathology review

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lisa D. Hobson-Webb, MD, Duke University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 2, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Myositis
• Other Study ID Numbers: Pro00041999