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Chronic Recurrent Multifocal Osteomyelitis - a Bacterial Cause?

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ClinicalTrials.gov Identifier: NCT03433287
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 15, 2018
Region Sjælland
Information provided by (Responsible Party):
Marie Øbro Fosbøl, Rigshospitalet, Denmark

Brief Summary:

Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Using existing knowledge of chronic infections combined with sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or disproving bacteria as the underlying etiology.

In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.

Condition or disease Intervention/treatment
Chronic Recurrent Multifocal Osteomyelitis Diagnostic Test: 18F-NaF-PET/MRI

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chronic Recurrent Multifocal Osteomyelitis - Search for a Bacterial Cause and Improving Imaging With PET/MRI
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: 18F-NaF-PET/MRI
Eligible patients who give informed consent will be offered a NaF -PET/MRI scan
Diagnostic Test: 18F-NaF-PET/MRI
PET/MRI scan after injection of 18F-labelled sodium fluoride

Primary Outcome Measures :
  1. Number of detected CRMO lesions [ Time Frame: 1 hour after PET/MRI scan ]
    Compare no. of detected CRMO lesions on PET/MRI and standard diagnostic tests

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CRMO diagnosis verified by biopsy
  • Age under 18 years at diagnosis
  • Malignant disease excluded
  • Informed written consent

Exclusion Criteria:

  • Bone biopsy not performed
  • Patients not eligible for MRI (metallic foreign objects, severe claustrophobia)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433287

Contact: Marie Ø Fosbøl 004531508808 marie.oebro.fosboel@regionh.dk

Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Marie Fosbøl    004531508808    marie.oebro.fosboel@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Region Sjælland
Principal Investigator: Lise Borgwardt, PhD Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Responsible Party: Marie Øbro Fosbøl, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03433287     History of Changes
Other Study ID Numbers: Protokol-49657
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases