Evaluation of the value of PET/MRI for diagnosis and treatment monitoring of patients with ankylosing Spondylitis before and after Treatment with a TNF-blocker
Not Applicable
Recruiting
- Conditions
- M45.09
- Registration Number
- DRKS00016917
- Lead Sponsor
- MSD Deutschland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Diagnosis of ankylosing spondylitis
Clinical indication for the onset of TNFa blocker therapy (BASDAI score of 4 despite prior treatment with at least 2 NSAIDs) over a period of at least one month
Adult patients with ankylosing spondylitis who are to receive 18F PET examination according to clinical indication
Written consent of the patient
Exclusion Criteria
Contraindication to an MRI examination (strong Claustrophobia, Non-removable, ferromagnetic foreign bodies, Pacemakers / ICD)·
Contraindication to MRI contrast agents (High-grade renal insufficiency (GFR x 30 mg/dl; serum creatinine > 1.75 mg/dl))
Mental illness that limits understanding of the study protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: <br>1.Investigation of the anti-inflammatory but also anti-osteoblastic effect of TNFa blockers over 3 months in patients with active ankylosing spondylitis, in whom the indication for therapy with a TNFa blocker based on clinically applicable criteria.<br>2.Investigation of the correlation of clinical disease activity with the extent and course of inflammatory changes (MRI) or increased metabolic (18F-PET) activity<br>
- Secondary Outcome Measures
Name Time Method Secondary endpoint<br>1.Comparison of the results of native MRI examinations in spine and sacroiliacal joints of patients with ankylosing spondylitis before and after 3 months of TNFa-blocker therapy with the results and findings obtained with 18F-PET/MRI. The exact locations of the axis skeleton showing inflammatory activity in MRI are to be compared in detail with exactly the anatomical regions that have metabolic activity in 18F-PET/MRI.<br>