Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia

NCT ID: NCT01506817

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-09-30

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.

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

Conditions

Fibromyalgia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Fibromyalgia

patients with fibromyalgia fulfilling the 1990-ACR research criteria and with pain in the hands as a prominent clinical feature

Dynamic contrast-enhanced MRI of the hands

Intervention Type: 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

healthy aged matched pain-free controls

Dynamic contrast-enhanced MRI of the hands

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oak Foundation

OTHER

Sponsor Role: collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henning Bliddal

Professor, MD, DMSci

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikael Boesen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute and Department of Radiology, Frederiksberg Hospital Denmark

Henning Bliddal, Professor, DMSci

Role: STUDY_DIRECTOR

The Parker Institute, Frederiksberg Hospital Denmark

Kirstine Amris, MD

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute and Department of Rheumatology, Frederiksberg Hospital Denmark

Peter Taylor, Professor, MA, PhD

Role: PRINCIPAL_INVESTIGATOR

Kennedy Institute of Rheumatology, University of Oxford, England

Locations

The Parker Institute, Frederiksberg University Hospital

Frederiksberg, , Denmark

Countries

Denmark

Related Links

http://www.frederiksberghospital.dk/parker

Related Info

Other Identifiers

HB-030112

Identifier Type: -

Identifier Source: org_study_id