PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

NCT ID: NCT02130271

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

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.

Conditions

Sciatica

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy

Healthy subjects with no pain.

• Radioactive dye
• PET/MRI
• Blood draw

Radioactive dye

Intervention Type: DRUG

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

PET/MRI

Intervention Type: RADIATION

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

Blood draw

Intervention Type: 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.

Sciatica

Subjects with sciatica and scheduled for an epidural steroid injection (ESI).

• Radioactive dye
• PET/MRI
• Blood draw

Radioactive dye

Intervention Type: DRUG

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

PET/MRI

Intervention Type: RADIATION

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

Blood draw

Intervention Type: 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.

Interventions

Radioactive dye

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

Intervention Type: DRUG

PET/MRI

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

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Other Intervention Names

[11C]PBR28; Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).

Eligibility Criteria

Inclusion Criteria

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.

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Zhang, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Zhang, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

MGH Center for Translational Pain Research

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P-002174

Identifier Type: -

Identifier Source: org_study_id