PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

NCT02130271 | Completed DMC

• 1 other identifier: 2013P-002174
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sciatica

Keywords

Sciatica; PET scan; MRI; Inflammation; Epidural Steroid Injection (ESI)

Outcome Measures

Primary Outcomes (1)

• Inflammation in the spine

  The presence of inflammation in the spine using the radioactive tracer \[11C\]PBR28.

  2 hours

Secondary Outcomes (1)

• Pain Scores on the Visual Analog Scale (VAS)

  up to 3 months

Study Arms (2)

Healthy

Healthy subjects with no pain. * Radioactive dye * PET/MRI * Blood draw

Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw

Sciatica

Subjects with sciatica and scheduled for an epidural steroid injection (ESI). * Radioactive dye * PET/MRI * Blood draw

Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw

Interventions

Radioactive dye DRUG

The radioactive dye \[11C\]PBR28 will be administered through an intravenous line (IV).

Also known as: [11C]PBR28

Healthy; Sciatica

PET/MRI RADIATION

All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.

Also known as: Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).

Healthy; Sciatica

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.

Healthy; Sciatica

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is 18-75 years old.
• Subject is able to give written informed consent.
• Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies.
• Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities.
• Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment.
• Subject is 18-75 years old.
• Subject is able to give written informed consent.
• Subject has no history of chronic back/spine pain.

You may not qualify if:

• Subject recently received a lumbar ESI (within 8 weeks).
• Subject starts new NSAID medication for pain during the study.
• Subject has predominantly axial low back pain.
• Subject has known pain condition secondary to hip joint arthritis.
• Subject is pregnant or breastfeeding.
• Subject has allergy to lidocaine.
• Subject is treated with chronic corticosteroid therapy.
• Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).
• Subject has a known bleeding disorder (i.e. hemophilia).
• Subject has uncontrolled high blood pressure \[\>170/100\].
• Subject has a known heart condition.
• Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing spondylitis; etc.).
• 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).
• Subject has been hospitalized recently (within one month) for a major psychiatric disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychosis).
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

Related Links

• MGH Center for Translational Pain Research

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Sciatica; Inflammation

Interventions

(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yi Zhang, MD, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

US (1)