Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia

NCT01506817 | Unknown

• 1 other identifier: HB-030112
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; DCE-MRI; neurogenic inflammation; contrast-enhancement patterns

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  at baseline

Study Arms (2)

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

Controls

healthy aged matched pain-free controls

Procedure: Dynamic contrast-enhanced MRI of the hands

Interventions

Dynamic contrast-enhanced MRI of the hands PROCEDURE

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; Fibromyalgia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
• Renal impairment
• Contraindications for MRI

Sponsors & Collaborators

• Frederiksberg University Hospital: lead
• Oak Foundation: collaborator

Study Sites (1)

The Parker Institute, Frederiksberg University Hospital

Frederiksberg, 2000, Denmark

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fibromyalgia; Neurogenic Inflammation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mikael Boesen, MD,PhD

  The Parker Institute and Department of Radiology, Frederiksberg Hospital Denmark

  PRINCIPAL INVESTIGATOR

• Henning Bliddal, Professor, DMSci

  The Parker Institute, Frederiksberg Hospital Denmark

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMSci

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 10, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

DK (1)