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
  Purpose

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.


Condition Intervention
Fibromyalgia
Procedure: Dynamic contrast-enhanced MRI of the hands

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fibromyalgia
patients with fibromyalgia fulfilling the 1990-ACR research criteria and with pain in the hands as a prominent clinical feature
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.
Controls
healthy aged matched pain-free controls
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506817

Locations
Denmark
The Parker Institute, Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Oak Foundation
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Henning Bliddal, Professor, MD, DMSci, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01506817     History of Changes
Other Study ID Numbers: HB-030112
Study First Received: January 3, 2012
Last Updated: January 5, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Frederiksberg University Hospital:
fibromyalgia
DCE-MRI
neurogenic inflammation
contrast-enhancement patterns

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014