Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy

June 8, 2020 updated by: Balgrist University Hospital

Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study

Prior to the injection, the facet joints have to be defined according to standard radiological techniques (e.g. MRI and physical correlation). Patients are then sent to 18F-Fluoride-PET/MRI imaging, in order to localize facet joints with increased uptake. Facet joints to be injected are again defined according to the location(s) of highest uptake as demonstrated by 18F-Fluoride-PET/MRI.

The defined injection sites before and after PET/MRI are compared. In equal defined injection sites, patients are sent for infiltration as scheduled, otherwise patients are randomized into two groups.

One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with standard injections performed under CT-guidance by the radiology department of the study site. The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI results, but based on current standard clinical practise (MRI and clinical correlation).

The patients are asked to complete a validated pain and function questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.

The purpose of this study is to prospectively evaluate the value of 18F-Fluoride-PET/MRI imaging in patients with low back pain with evidence of painful facet joint arthropathy, which would potentially benefit from facet joint injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8008
        • University Clinic Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients over 18 years old with low back pain who have failed conservative management in the primary care setting, namely, analgesia and physical therapy.
  2. Imaging evidence (e.g. MRI) of facet joint degeneration, such as facet hypertrophy, subchondral sclerosis, and joint space narrowing.
  3. Obtained informed consent

Exclusion Criteria:

  1. had undergone prior spinal surgery or prior facet joint injections or
  2. had other spinal abnormalities (benign or malignant tumors, congenital defects, isthmic spondylolisthesis) or
  3. are unable to tolerate PET/MRI imaging
  4. are pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: injection based on 18F-Fluoride-PET/MRI
One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with standard injections performed under CT-guidance. The Pain assessment by VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
Device: 18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
Procedure: facet injection
facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
Other: pain assessment by VAS
VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
Active Comparator: injection based on clinical practise
The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI results, but based on current standard clinical practise (MRI and clinical correlation). Pain assessment by VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
Device: 18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
Procedure: facet injection
facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
Other: pain assessment by VAS
VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain reduction
Time Frame: VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection
reduction of pain after facet joint injection assessed by visual analogue scale (VAS)
VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
location of uptake in 18F-Fluoride-PET/MRI
Time Frame: 40 +/- 7 days post injection
location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
40 +/- 7 days post injection
quantity of uptake in 18F-Fluoride-PET/MRI
Time Frame: 40 +/- 7 days post injection
quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
40 +/- 7 days post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Collaborators

University of Zurich

Investigators

  • Principal Investigator: Mazda Farshad, PD Dr. med., Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

April 24, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET/MRI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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