PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

Sciatica Clinical Trial

Official title:

PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130271
• Other study ID #: 2013P-002174
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Sciatica

Intervention

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

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

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.

Locations

Country	Name	City	State
United States	MGH Center for Translational Pain Research	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation in the spine	The presence of inflammation in the spine using the radioactive tracer [11C]PBR28.	2 hours
Secondary	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

External Links

•   MGH Center for Translational Pain Research