PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

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

Study Overview

• Status: Completed
• Conditions: Sciatica
• Intervention / Treatment: Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Center for Translational Pain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Subject is currently diagnosed with lower extremity radicular/sciatica pain.
2. Healthy subjects with no pain from the local community.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Healthy subjects with no pain.; Radioactive dye; PET/MRI; Blood draw	Drug: Radioactive dye; The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).; Other Names: [11C]PBR28; Radiation: PET/MRI; All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.; Other Names: Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).; Other: 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.
Sciatica; Subjects with sciatica and scheduled for an epidural steroid injection (ESI).; Radioactive dye; PET/MRI; Blood draw	Drug: Radioactive dye; The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).; Other Names: [11C]PBR28; Radiation: PET/MRI; All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.; Other Names: Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation in the spine	The presence of inflammation in the spine using the radioactive tracer [11C]PBR28.	2 hours

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Yi Zhang, MD, PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Inflammation; Sciatica; PET scan; Epidural Steroid Injection (ESI)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Inflammation
• Other Study ID Numbers: 2013P-002174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No