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Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Oak Foundation
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01506817
First received: January 3, 2012
Last updated: January 5, 2012
Last verified: January 2012

January 3, 2012
January 5, 2012
December 2011
September 2012   (final data collection date for primary outcome measure)
Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study. [ Time Frame: at baseline ] [ Designated as safety issue: No ]
The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil.
Same as current
Complete list of historical versions of study NCT01506817 on ClinicalTrials.gov Archive Site
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Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia
Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study

The primary objective of the current pilot study is to analyze MRI contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic arthritis.

Hypothesis:

Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g. superficial soft tissues and /or muscle with patterns distinct from those of inflammatory joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.

Systematic, diagnostic studies applying DCE-MRI have never been performed in patients with fibromyalgia. However, characteristic contrast-enhancement patterns different from those seen in patients with rheumatoid arthritis and psoriatic arthritis have been observed in a small sample of fibromyalgia patients referred for DCE-MRI of the hands for differential diagnostic purposes at department of radiology, Frederiksberg Hospital. In these patients enhancement parameters indicative of vasodilatation and diffuse hyperperfusion involving subcutaneous tissues and muscles of the hands and fingers were found, whereas no synovial inflammation in joints or tendons could be demonstrated in the majority of these patients. Whether these observations are part of a "normal" physiological perfusion in healthy individual or a potential novel marker of disease activity remains to be studied.

If a pathological imaging pattern indicative of superficial soft tissue or muscle inflammation/hyper perfusion can be demonstrated it will have far-reaching implications for future research related to this patient population. Not only may this line of research contribute to a better neurobiological understanding of fibromyalgia and the neurobiological link between inflammation and pain modulation, but also to the development of more objective examination methods, which will make diagnosing more reliable and less subjective. Further, a better understanding of the neurobiology and phenomenological manifestations of fibromyalgia may have critical treatment implications

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients with fibromyalgia recruited from Department of Rheumatology, Frederiksberg Hospital. Inclusion in the study will be based on clinical assessment by a specialist in rheumatology and member of the research team. Patients fulfilling the 1990-ACR criteria for fibromyalgia and with pain in the hands as a prominent clinical feature will be referred for DCE-MRI as part of the diagnostic workup.

Healthy controls will be recruited by advertisement at www.forsøgsperson.dk or in the daily press and included in the project based on written, informed consent.

Fibromyalgia
Procedure: Dynamic contrast-enhanced MRI of the hands
The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil. Total imaging time varies between 30-35 minutes.
  • Fibromyalgia
    patients with fibromyalgia fulfilling the 1990-ACR research criteria and with pain in the hands as a prominent clinical feature
    Intervention: Procedure: Dynamic contrast-enhanced MRI of the hands
  • Controls
    healthy aged matched pain-free controls
    Intervention: Procedure: Dynamic contrast-enhanced MRI of the hands
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age above 18
  • Fibromyalgia according to the 1990-ACR research criteria
  • Pain in the hands as a prominent clinical feature

Exclusion Criteria:

  • Other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
  • Renal impairment
  • Contraindications for MRI
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01506817
HB-030112
Not Provided
Henning Bliddal, Frederiksberg University Hospital
Frederiksberg University Hospital
Oak Foundation
Principal Investigator: Mikael Boesen, MD,PhD The Parker Institute and Department of Radiology, Frederiksberg Hospital Denmark
Study Director: Henning Bliddal, Professor, DMSci The Parker Institute, Frederiksberg Hospital Denmark
Principal Investigator: Kirstine Amris, MD The Parker Institute and Department of Rheumatology, Frederiksberg Hospital Denmark
Principal Investigator: Peter Taylor, Professor, MA, PhD Kennedy Institute of Rheumatology, University of Oxford, England
Frederiksberg University Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP