Overview

This trial is active, not recruiting.

Condition sciatica
Treatments radioactive dye, pet/mri, blood draw
Sponsor Massachusetts General Hospital
Start date April 2014
End date December 2016
Trial size 42 participants
Trial identifier NCT02130271, 2013P-002174

Summary

The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Healthy subjects with no pain. Radioactive dye PET/MRI Blood draw
radioactive dye [11C]PBR28
The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).
pet/mri Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).
All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.
blood draw
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.
Subjects with sciatica and scheduled for an epidural steroid injection (ESI). Radioactive dye PET/MRI Blood draw
radioactive dye [11C]PBR28
The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).
pet/mri Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).
All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.
blood draw
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.

Primary Outcomes

Measure
Inflammation in the spine
time frame: 2 hours

Secondary Outcomes

Measure
Pain Scores on the Visual Analog Scale (VAS)
time frame: up to 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients
Principal investigator Yi Zhang, MD, PhD.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.