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The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).
The purpose of this study is to determine if inflammation around the spinal nerves can be identified using a radioactive tracer [11C] PBR28 and integrated PET/MRI scan for the purpose of better treating patients who have radicular lumbar pain with epidural steroid injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Healthy subjects with no pain.
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| |
| Sciatica | Subjects with sciatica and scheduled for an epidural steroid injection (ESI).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive dye | Drug | The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation in the spine | The presence of inflammation in the spine using the radioactive tracer [11C]PBR28. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale (VAS) | The subject's pain score (VAS) at baseline and up to 3 months after the ESI treatment. | up to 3 months |
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Inclusion criteria for pain subjects:
Inclusion criteria for healthy subjects:
Exclusion criteria for all groups:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, MD, PhD. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Center for Translational Pain Research | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| MGH Center for Translational Pain Research | View source |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C526315 | (methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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A blood sample will be taken from healthy subjects only at Visit 1. The blood sample will genotyped. Genotyping will identify if the subject makes proteins that will bind the radioactive tracer.
A blood sample will be drawn for Genotyping at Visit 2 from all subjects.
| PET/MRI | Radiation | All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long. |
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| Blood draw | Other | Up to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers. |
|
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |