* To study the relationship between inflammation on MRI and syndesmophyte formation with very detailedimaging methods: radiography, computed tomography (CT), 3 and 7 Tesla MRI. * To examine the time order of pathologic changes like inflammation,…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Autoimmune disorders
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study whether there is a relationship between local inflammation and the
development of new syndesmophytes at the same site in a vertebral unit in
patients with ankylosing spondylitis:
• Direct causal relationship: local inflammation * syndesmophyte formation
• Indirect causal relationship: inflammation * local changes * resolved
inflammation * syndesmophyte formation
Secondary outcome
• To examine the time order of pathologic changes (e.g. inflammation, fatty
degeneration, erosion, syndesmophyte formation).
• To examine the exact location of inflammation in a vertebral unit.
• To test the hypothesis that syndesmophyte formation occurs at sites with
complete normal anatomy without inflammation.
• To assess the agreement between 3 and 7 Tesla MRI in detecting sites of
inflammation
• To assess the agreement between CT and conventional radiography of the
cervical and lumbar spine in detecting structural changes.
• To examine if the thoracic spine provides different information compared to
the cervical and lumbar spine.
Background summary
Ankylosing spondylitis (AS) is an inflammatory disease characterized by chronic
inflammation in the spine. Ultimately, patients develop syndesmophytes, bony
spikes at corners of vertebrae resulting in bony bridges. Conventional
radiography is able to visualize syndesmophyte formation, which can already be
detected after a one year interval. However, two years are advised to see
sufficient changes in many patients. Inflammatory changes can already be
detected using magnetic resonance imaging (MRI) in an earlier disease stage.
The general hypothesis is that inflammation precedes bone formation; however,
currently available data do not support this hypothesis. There is no
relationship between the overall level of inflammation in the spine and the
number of new syndesmophytes. Detailed analyses of vertebral inflammation and
syndesmophyte formation in the same unit show that it is slightly more likely
that syndesmophytes are formed in vertebrae with inflammation compared to those
without inflammation. However, the majority of syndesmophytes are formed in
vertebrae in which no inflammation was present over a two year period. Anti-TNF
agents are very effective in suppressing MRI inflammation, but are unable to
inhibit syndesmophyte formation.
Study objective
* To study the relationship between inflammation on MRI and syndesmophyte
formation with very detailed
imaging methods: radiography, computed tomography (CT), 3 and 7 Tesla MRI.
* To examine the time order of pathologic changes like inflammation, fatty
degeneration, erosion and syndesmophyte
formation.
* To assess agreement between 3 and 7 Tesla MRI in detecting inflammation.
* To assess agreement between CT and conventional radiography of the cervical
and lumbar spine in detecting
structural changes.
* To examine if the thoracic spine provides different information compared to
the cervical and lumbar spine.
Study design
This is a prospective follow-up study using a cohort of patients with
ankylosing spondylitis. Consenting patients will have both clinical and
radiological assessments. Patients will be studied over a two year period with
annual (MRI) and biennial (radiography, CT) imaging of the spine.
Study burden and risks
Thirty patients with Ankylosing Spondylitis will be studied for a period of 2
years. Each visit (to a total of 3) will take about 4 hours.
Visit 1 (t=0)
* department of rheumatology: interview, physical examination, questionnaires,
venous punction
* department of radiology: X-CWK / X-LWK / CT-scan / 3 Tesla MRI -scan/ 7 Tesla
MRI-scan
Visit 2 (t=12 months)
* department of rheumatology: interview, physical examination, questionnaires,
venous punction
* department of radiology: 3 Tesla MRI -scan / 7 Tesla MRI-scan
Visit 3 (t=24 maanden)
* department of rheumatology: interview, physical examination, questionnaires,
venous punction
* department of radiology: X-CWK / X-LWK / CT-scan / 3 Tesla MRI -scan/ 7 Tesla
MRI-scan
Burden / risks for the patient:
* Three venous punctions which may be perceived as painful.
* X-rays and CT-scans use radiation. Exposure to radiation is a risk for
developing cancer. However, the risk on developing cancer due to X-rays is very
small. Concerning the CT-scans: the total radiation dose is estimated to be 2 x
4 msV = 8 msV effective dose. This effective dose is judged as 'high' and
places this research in category IIb according to European guidelines. Category
IIb states that 'the proposed research has to be judged on the criterion:
research of social relevance, meant for diagnosis, treatment of prevention',
which is the case in our study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
a) Male and female patients of at least 18 years having Ankylosing Spondylitis (AS) fulfilling the Modified New York criteria, in which a patient has *definite* AS if the radiological criterion is associated with at least one clinical criterion: ;Clinical criterions:
* low back pain and stiffness for more than 3 months that improves with exercise, but is not relieved by rest.
* limitation of motion of the lumbar spine in the sagittal and frontal planes.
* limitation of chest expansion relative to normal values correlated for age and sex.;Radiological criterion (sacroiliitis grade >= 2 bilaterally or grade 3-4 unilaterally)
* grade 0 = no sacroiliitis
* grade 1 = blurring of the joint margins (*suspicious*)
* grade 2 = sclerosis, erosions, no changes in joint space
* grade 3 = erosions, changes in joint space, partial ankylosis
* grade 4 = complete ankylosis;b) Patients should have at least one syndesmophyte in either the cervical or lumbar spine radiograph at baseline conventional radiography. The maximum number of VUs is 9 (out of 12). ;c) The patient should have given written informed consent.
Exclusion criteria
* > 9 by syndesmophytes affected vertebral units.;* A history of alcoholism, drug abuse, psychological or other emotional problems, severe comorbidity likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements.;* Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD, vascular clips, hearing aids and claustrophobia).;* Pregnancy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30927.058.09 |