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Completed

NCT Number: NCT02130271

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for pain subjects:

  • 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.

Inclusion criteria

for healthy subjects:

  • Subject is 18-75 years old.
  • Subject is able to give written informed consent.
  • Subject has no history of chronic back/spine pain.

Exclusion criteria

for all groups:

  • 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).
  • Subject had research-related radiation exposure in the last 12 months.
  • Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.

Treatment and study plan

Radioactive dye

Drug

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

Other names: [11C]PBR28

PET/MRI

Radiation

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).

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.

Primary outcomes

  1. Inflammation in the spine

    Time frame: 2 hours

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

Secondary outcomes

  1. Pain Scores on the Visual Analog Scale (VAS)

    Time frame: up to 3 months

    The subject's pain score (VAS) at baseline and up to 3 months after the ESI treatment.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 5, 2014
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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