Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Active, not recruiting

• Conditions: Lower Back Pain Chronic
• Interventions: Diagnostic Test: [18F]NaF PET/CT scan

• Registration Number: NCT05801848
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-05
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age matched healthy controls	[18F]NaF PET/CT scan	Healthy individuals without any previously known pain or intervention on lower back
Chronic lower back pain patients	[18F]NaF PET/CT scan	Patients with chronic lower back pain where the source could not be identified on MRI scans

Primary Outcome Measures

Name	Time	Method
Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion	1 hour examination	\[18F\]NaF PET/CT scan

Trial Locations

Locations (1)

Rigshospitalet - Centre of Rheumatology and Spine Disease; 🇩🇰 Glostrup, Denmark