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Active, Not Recruiting

NCT Number: NCT05801848

Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lower Back Pain Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet - Centre of Rheumatology and Spine Disease

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]NaF PET/CT scan

Diagnostic Test

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

Primary outcomes

  1. Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion

    Time frame: 1 hour examination

    [18F]NaF PET/CT scan

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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