Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Lower Back Pain Chronic Clinical Trial

Official title:

Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05801848
• Other study ID #: H-19039428
• Status: Active, not recruiting
• Start date: March 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of [18F]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients. Hypothesis: That [18F]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain Chronic

Intervention

Diagnostic Test:
• [18F]NaF PET/CT scan
Patients will have their lower back scanned using [18F]NaF PET/CT

Locations

Country	Name	City	State
Denmark	Rigshospitalet - Centre of Rheumatology and Spine Disease	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion	[18F]NaF PET/CT scan	1 hour examination