Ultrasound in Muscle Biopsy

NCT01790178 | Completed Results

• 1 other identifier: Pro00041999
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopathy; Myositis; Muscular Dystrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants With Adverse Events Related to Muscle Biopsy

  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

  At time of biopsy

• Number of Participants With Inadequate Biopsy Samples

  At time of pathology review

Study Arms (2)

Ultrasound Guided Biopsy

EXPERIMENTAL

Ultrasound guided biopsy will be used in all patients.

Procedure: Ultrasound

Non-Ultrasound Guided Group

NO INTERVENTION

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.

Interventions

Ultrasound PROCEDURE

The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.

Ultrasound Guided Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age under 18 years.
• Inability to provide consent for participation.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Muscular Diseases; Myositis; Muscular Dystrophies

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Disorders, Atrophic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Lisa Hobson-Webb
• Organization: Duke University

lisa.hobsonwebb@dm.duke.edu

919-668-2277

Study Officials

• Lisa D. Hobson-Webb, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 2, 2017
• Results First Posted: November 15, 2016

Record last verified: 2016-11

Locations

US (1)