Trial Outcomes & Findings for Ultrasound in Muscle Biopsy (NCT NCT01790178)

Results Overview

This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

At time of biopsy

Results posted on

2017-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound Guided Biopsy 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.	Non-Ultrasound Guided Group The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Overall Study STARTED	16	24
Overall Study COMPLETED	16	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound in Muscle Biopsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	21 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	56.1875 years STANDARD_DEVIATION 19.8 • n=5 Participants	55.375 years STANDARD_DEVIATION 12.8 • n=7 Participants	55.7 years STANDARD_DEVIATION 15.7 • n=5 Participants
Gender Female	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	24 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Amount of Tissue Obtained	0.29 grams Standard Deviation 0.23	0.28 grams Standard Deviation 0.21

PRIMARY outcome

Timeframe: At time of biopsy

The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.

Outcome measures

Outcome measures
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Number of Patients Receiving Diagnosis From Muscle Biopsy	7 participants	12 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Number of Participants With Adverse Events Related to Muscle Biopsy	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue	2.57 needle passes Standard Deviation 0.756	2.5 needle passes Standard Deviation 0.761

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasound Guided Biopsy n=16 Participants 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.	Non-Ultrasound Guided Group n=24 Participants The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
Number of Participants With Inadequate Biopsy Samples	1 Inadequate Biopsy Samples	2 Inadequate Biopsy Samples

Adverse Events

Ultrasound Guided Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Ultrasound Guided Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Hobson-Webb

Duke University

Phone: 919-668-2277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place