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FDG PET/MRI Evaluation of Facet Joint Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG PET/MR examination.
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility criteria - inclusion:

  1. Male and female patients over the age of 50-100 years with clinically suspected facetogenic low back pain.
  2. Patients must be considered to have at least a 60% chance of having facet joints as the major source of low back pain based on overall clinical impression.
  3. All patients will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain.
  4. Patients with either unilateral or bilateral axial low back pain may be enrolled.

Eligibility criteria - exclusion:

  1. Pregnancy
  2. Prior lumbar back surgery
  3. History of endovascular repair of abdominal aortic aneurysm or other postoperative change likely to introduce imaging artifact to the lumbar spine
  4. Suspected spine infection
  5. Known osseous metastatic or other osseous malignancy
  6. Facet joint percutaneous treatment within the past 2 months
  7. History of major lumbar spine trauma
  8. Inability to provide own consent
  9. Claustrophobia, cardiac pacemaker/wires in place, any absolute contraindication to MRI
  10. Impaired renal function indicated by a GFR less than 30
  11. Gadolinium allergy
  12. Highly radiosensitive medical conditions
  13. Patients who are unable to lay quietly for 60 minutes of imaging

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MR recipients

Arm Description

All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.

Outcomes

Primary Outcome Measures

Facet Joint High Grade FDG Activity Concordance to Pain
Concordance of high grade FDG scores with clinical impression
Facet Joint All Grades of FDG Activity Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Facet Joint High Grade MRI Signal Change Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Facet Joint Any Grade of MRI Signal Change Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Facet Joint High Grade FDG Activity Potential Effect on Management
Number/percentage of subjects for whom high grade FDG scores would change clinical management
Facet Joint All Grades of FDG Activity Potential Effect on Management
Number/percentage of subjects for whom any grade FDG scores would change clinical management
Facet Joint High Grade MRI Signal Change Potential Effect on Management
Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management
Facet Joint Any Grade MRI Signal Change Potential Effect on Management
Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management

Secondary Outcome Measures

Full Information

First Posted
September 29, 2016
Last Updated
February 7, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02921490
Brief Title
FDG PET/MRI Evaluation of Facet Joint Pain
Official Title
Molecular and Magnetic Resonance Imaging Biomarkers of Facet Joint Pain of the Lumbar Spine With PET/MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost wages, etc) annually. The most common source is low back pain (LBP), often from facet joints. The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can cost thousands of dollars per session and delay diagnoses. Very limited retrospective information suggests that high grade peri-facet MRI signal change correlates to the side of LBP. However, this has not fully characterized the imaging findings and has not correlated to expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact. Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams, but the evidence of correlation to patient pain is lacking. Limited DWI exists for inflammatory spondyloarthropathies and myopathies, but is also lacking. This is an exploratory study investigating the utility of FDG PET activity and MRI signal change around facet joints in the clinical management of low back pain. This study will help determine if such imaging biomarkers could change clinical management. Additionally, this will provide data that will be vital to planning a larger prospective study evaluating the ability of imaging biomarkers to predict response to comparison medial branch blocks and RF ablation for treatment of facet joint pain.
Detailed Description
10 patients with a clinical suspicion of at least 60% likelihood that low back pain arises from the lumbar facet joints will be recruited in clinic. The clinicians will rate the likelihood clinically of facet joint origin of pain and will assign a theoretical treatment plan based on initial clinical impression. They will indicate which facet joints, if any, they would refer for percutaneous treatment. The patients will undergo and FDG PET/MRI of the lumbar spine with IV gadolinium. The MRI signal change and enhancement of the lumbar facet joints will be graded by 2 radiologists blinded to the clinical data. The FDG PET scan activity of the facet joints will be graded by two nuclear medicine radiologists blinded to the clinical information. The clinicians will then be segmentally unblended to the imaging data as follows: 1. facet joints with high grade MRI signal change, 2. facet joints with any MRI signal change, 3. facet joints with high grade PET activity, and 4. facet joints with any PET activity. At each of these 4 steps, the clinician will indicate if this information would have the potential to alter clinical care (assuming that the imaging biomarker in question would be a surrogate for inflammation and pain) and if the information is concordant to the clinical impression. The clinical course of each patients will be followed for 1 year after undergoing the PET/MRI examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/MR recipients
Arm Type
Experimental
Arm Description
All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.
Intervention Type
Device
Intervention Name(s)
FDG PET/MR examination.
Intervention Description
All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Primary Outcome Measure Information:
Title
Facet Joint High Grade FDG Activity Concordance to Pain
Description
Concordance of high grade FDG scores with clinical impression
Time Frame
2 years
Title
Facet Joint All Grades of FDG Activity Concordance to Pain
Description
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time Frame
2 years
Title
Facet Joint High Grade MRI Signal Change Concordance to Pain
Description
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time Frame
2 years
Title
Facet Joint Any Grade of MRI Signal Change Concordance to Pain
Description
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time Frame
2 years
Title
Facet Joint High Grade FDG Activity Potential Effect on Management
Description
Number/percentage of subjects for whom high grade FDG scores would change clinical management
Time Frame
2 years
Title
Facet Joint All Grades of FDG Activity Potential Effect on Management
Description
Number/percentage of subjects for whom any grade FDG scores would change clinical management
Time Frame
2 years
Title
Facet Joint High Grade MRI Signal Change Potential Effect on Management
Description
Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management
Time Frame
2 years
Title
Facet Joint Any Grade MRI Signal Change Potential Effect on Management
Description
Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility criteria - inclusion: Male and female patients over the age of 50-100 years with clinically suspected facetogenic low back pain. Patients must be considered to have at least a 60% chance of having facet joints as the major source of low back pain based on overall clinical impression. All patients will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain. Patients with either unilateral or bilateral axial low back pain may be enrolled. Eligibility criteria - exclusion: Pregnancy Prior lumbar back surgery History of endovascular repair of abdominal aortic aneurysm or other postoperative change likely to introduce imaging artifact to the lumbar spine Suspected spine infection Known osseous metastatic or other osseous malignancy Facet joint percutaneous treatment within the past 2 months History of major lumbar spine trauma Inability to provide own consent Claustrophobia, cardiac pacemaker/wires in place, any absolute contraindication to MRI Impaired renal function indicated by a GFR less than 30 Gadolinium allergy Highly radiosensitive medical conditions Patients who are unable to lay quietly for 60 minutes of imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vance T Lehman
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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FDG PET/MRI Evaluation of Facet Joint Pain

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