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
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||Phase|
|Chronic Recurrent Multifocal Osteomyelitis||Diagnostic Test: 18F-NaF-PET/MRI||Not Applicable|
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)|
|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|
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
- 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
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 Fosbølemail@example.com|
|Copenhagen, Denmark, 2100|
|Contact: Marie Fosbøl 004531508808 firstname.lastname@example.org|
|Principal Investigator:||Lise Borgwardt, PhD||Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET|