Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01506817
• Other study ID #: HB-030112
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 3, 2012
• Last updated: January 5, 2012
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg University Hospital	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Oak Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No