Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

NCT05801848 | Active Not Recruiting DMC

• 1 other identifier: H-19039428
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to determine if static or dynamic \[18F\]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.

Conditions

Lower Back Pain Chronic

Keywords

NaF PET; Bone metabolism; Bone perfusion

Outcome Measures

Primary Outcomes (1)

• Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion

  \[18F\]NaF PET/CT scan

  1 hour examination

Study Arms (2)

Chronic lower back pain patients

Patients with chronic lower back pain where the source could not be identified on MRI scans

Diagnostic Test: [18F]NaF PET/CT scan

Age matched healthy controls

Healthy individuals without any previously known pain or intervention on lower back

Diagnostic Test: [18F]NaF PET/CT scan

Interventions

[18F]NaF PET/CT scan DIAGNOSTIC_TEST

Patients will have their lower back scanned using \[18F\]NaF PET/CT

Age matched healthy controls; Chronic lower back pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic lower back pain where the source could not be identified on MRI scans

You may qualify if:

• Over 18 years
• Chronic lower back pain with no concrete diagnosis after MRI and/or CT
• Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease

You may not qualify if:

• previous operation in the lower back area
• Known inflammatory related illness or progressive rheumatism

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator

Study Sites (1)

Rigshospitalet - Centre of Rheumatology and Spine Disease

Glostrup Municipality, 2600, Denmark

Location

Related Publications (2)

• Gamie S, El-Maghraby T. The role of PET/CT in evaluation of Facet and Disc abnormalities in patients with low back pain using (18)F-Fluoride. Nucl Med Rev Cent East Eur. 2008;11(1):17-21.

  PMID: 19173183 RESULT

• Kogan F, Broski SM, Yoon D, Gold GE. Applications of PET-MRI in musculoskeletal disease. J Magn Reson Imaging. 2018 Jul;48(1):27-47. doi: 10.1002/jmri.26183.

  PMID: 29969193 RESULT

Study Officials

• Rune Tønnesen, MD PhD

  Rigshospitalet Centre of Rheumatology and Spine Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: March 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)