PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

Completed

• Conditions: Sciatica
• Interventions: Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw

• Registration Number: NCT02130271
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Primary Completion: 2016-12
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sciatica	Blood draw	Subjects with sciatica and scheduled for an epidural steroid injection (ESI). * Radioactive dye * PET/MRI * Blood draw
Healthy	Radioactive dye	Healthy subjects with no pain. * Radioactive dye * PET/MRI * Blood draw
Sciatica	Radioactive dye	Subjects with sciatica and scheduled for an epidural steroid injection (ESI). * Radioactive dye * PET/MRI * Blood draw
Healthy	PET/MRI	Healthy subjects with no pain. * Radioactive dye * PET/MRI * Blood draw
Sciatica	PET/MRI	Subjects with sciatica and scheduled for an epidural steroid injection (ESI). * Radioactive dye * PET/MRI * Blood draw
Healthy	Blood draw	Healthy subjects with no pain. * Radioactive dye * PET/MRI * Blood draw

Primary Outcome Measures

Name	Time	Method
Inflammation in the spine	2 hours	The presence of inflammation in the spine using the radioactive tracer \[11C\]PBR28.

Secondary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale (VAS)	up to 3 months	The subject's pain score (VAS) at baseline and up to 3 months after the ESI treatment.

Trial Locations

Locations (1)

MGH Center for Translational Pain Research; 🇺🇸 Boston, Massachusetts, United States