PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients



Status:Active, not recruiting
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:April 2014
End Date:December 2018

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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.

Inclusion criteria for pain subjects:

1. Subject is 18-75 years old.

2. Subject is able to give written informed consent.

3. Subject is currently diagnosed with lower extremity radicular pain regardless of
specific or suspected etiologies.

4. Subject has a clear dermatomal distribution of the painful area extending to the
distal lower extremities.

5. Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale
(VAS) during the week prior to enrollment.

Inclusion criteria for healthy subjects:

1. Subject is 18-75 years old.

2. Subject is able to give written informed consent.

3. Subject has no history of chronic back/spine pain.

Exclusion criteria for all groups:

1. Subject recently received a lumbar ESI (within 8 weeks).

2. Subject starts new NSAID medication for pain during the study.

3. Subject has predominantly axial low back pain.

4. Subject has known pain condition secondary to hip joint arthritis.

5. Subject is pregnant or breastfeeding.

6. Subject has allergy to lidocaine.

7. Subject is treated with chronic corticosteroid therapy.

8. Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).

9. Subject has a known bleeding disorder (i.e. hemophilia).

10. Subject has uncontrolled high blood pressure [>170/100].

11. Subject has a known heart condition.

12. Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing
spondylitis; etc.).

13. Subject has known liver dysfunction or renal insufficiency or impaired elimination
(Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥
3x ULN).

14. Subject has been hospitalized recently (within one month) for a major psychiatric
disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or
psychosis).

15. Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac
pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the
head or previous neurosurgery, prosthetic heart valves, or claustrophobia).

16. Subject had research-related radiation exposure in the last 12 months.

17. Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.
We found this trial at
1
site
Boston, Massachusetts 02114
Principal Investigator: Yi Zhang, MD, PhD
Phone: 617-724-6102
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mi
from
Boston, MA
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