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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Guided Biopsy | Experimental | Ultrasound guided biopsy will be used in all patients. |
|
| Non-Ultrasound Guided Group | No Intervention | The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Procedure | The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa D. Hobson-Webb, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Non-Ultrasound Guided Group | The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-Ultrasound Guided Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | grams | At time of biopsy |
|
Time of consent to Six months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Hobson-Webb | Duke University | 919-668-2277 | lisa.hobsonwebb@dm.duke.edu |
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| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009220 | Myositis |
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020966 | Muscular Disorders, Atrophic |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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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 |
The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Number | participants | At time of biopsy |
|
|
|
| Secondary | 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. | Posted | Number | participants | Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | needle passes | At time of biopsy |
|
|
|
| Secondary | 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. | Posted | Number | Inadequate Biopsy Samples | At time of pathology review |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Non-Ultrasound Guided Group | The control group will have non-ultrasound guided biopsies performed, which is the current standard of care. | 0 | 24 | 0 | 24 |
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| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055585 |
| Physical Phenomena |