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Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05801848
Enrollment
50
Registered
2023-04-06
Start date
2023-03-05
Completion date
2026-12-31
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Back Pain Chronic

Keywords

NaF PET, Bone metabolism, Bone perfusion

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.

Interventions

DIAGNOSTIC_TEST[18F]NaF PET/CT scan

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

Sponsors

Herlev Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion1 hour examination\[18F\]NaF PET/CT scan

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026