NCT03433287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

February 8, 2018

Last Update Submit

May 23, 2022

Conditions

Chronic Recurrent Multifocal Osteomyelitis

Outcome Measures

Primary Outcomes (1)

  • Number of detected CRMO lesions

    Compare no. of detected CRMO lesions on PET/MRI and standard diagnostic tests

    1 hour after PET/MRI scan

Study Arms (1)

18F-NaF-PET/MRI

EXPERIMENTAL

Eligible patients who give informed consent will be offered a NaF -PET/MRI scan

Diagnostic Test: 18F-NaF-PET/MRI

Interventions

18F-NaF-PET/MRIDIAGNOSTIC_TEST

PET/MRI scan after injection of 18F-labelled sodium fluoride

18F-NaF-PET/MRI

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Chronic recurrent multifocal osteomyelitis

Study Officials

  • Lise Borgwardt, PhD

    Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Open cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 14, 2018

Study Start

November 1, 2015

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

DK(1)