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Trial record 76 of 215 for:    Inflammatory Myopathies

Ultrasound in Muscle Biopsy

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ClinicalTrials.gov Identifier: NCT01790178
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : November 15, 2016
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Conditions Myopathy
Myositis
Muscular Dystrophy
Intervention Procedure: Ultrasound
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Period Title: Overall Study
Started 16 24
Completed 16 24
Not Completed 0 0
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group Total
Hide Arm/Group Description

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. Total of all reporting groups
Overall Number of Baseline Participants 16 24 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 24 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  37.5%
21
  87.5%
27
  67.5%
>=65 years
10
  62.5%
3
  12.5%
13
  32.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 24 participants 40 participants
56.1875  (19.8) 55.375  (12.8) 55.7  (15.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 24 participants 40 participants
Female
9
  56.3%
17
  70.8%
26
  65.0%
Male
7
  43.8%
7
  29.2%
14
  35.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 24 participants 40 participants
16 24 40
1.Primary Outcome
Title Amount of Tissue Obtained
Hide Description This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).
Time Frame At time of biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description:

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Number of Participants Analyzed 16 24
Mean (Standard Deviation)
Unit of Measure: grams
0.29  (0.23) 0.28  (0.21)
2.Primary Outcome
Title Number of Patients Receiving Diagnosis From Muscle Biopsy
Hide Description The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.
Time Frame At time of biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description:

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Number of Participants Analyzed 16 24
Measure Type: Number
Unit of Measure: participants
7 12
3.Secondary Outcome
Title Number of Participants With Adverse Events Related to Muscle Biopsy
Hide Description Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.
Time Frame Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description:

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Number of Participants Analyzed 16 24
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue
Hide Description 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.
Time Frame At time of biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description:

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Number of Participants Analyzed 16 24
Mean (Standard Deviation)
Unit of Measure: needle passes
2.57  (0.756) 2.5  (0.761)
5.Secondary Outcome
Title Number of Participants With Inadequate Biopsy Samples
Hide Description 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.
Time Frame At time of pathology review
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description:

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Number of Participants Analyzed 16 24
Measure Type: Number
Unit of Measure: Inadequate Biopsy Samples
1 2
Time Frame Time of consent to Six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Hide Arm/Group Description

Ultrasound guided biopsy will be used in all patients.

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

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
All-Cause Mortality
Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultrasound Guided Biopsy Non-Ultrasound Guided Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/24 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lisa Hobson-Webb
Organization: Duke University
Phone: 919-668-2277
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01790178     History of Changes
Other Study ID Numbers: Pro00041999
First Submitted: February 11, 2013
First Posted: February 13, 2013
Results First Submitted: August 1, 2016
Results First Posted: November 15, 2016
Last Update Posted: January 2, 2017