Trial document




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  DRKS00003317

Trial Description

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Title

Molecular Imaging of inflammatory joint pathologies of the hand in rheumatoid arthritis patients with Hybrid-PET-SPECT

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The combination of Magnet Resonance Imaging (MRI) with Single-Photo-Emission Tomography (SPECT) or Positron Emission Tomography (PET) are new imaging techniques, which allow for detection of malignant and inflammatory pathologies on a molecular basis. Both techniques can visualize early inflammatory changes of the bone metabolism (SPECT) and soft tissue metabolism (PET) of finger joints in rheumatoid arthritis (RA) with high resolution. The purpose of this study is to compare findings from PET, SPECT and MRI of the hand in patients with RA. Further the course of these inflammatory joint changes under antirheumatic therapy is evaluated. Knowledge of the connection between structural visible joint changes and metabolic changes might contribute to the understanding of the development of RA. These new imaging techniques are promising for a earlier disease detection because changes of metabolism might be already present prior to visibilty of structural changes on MRI scans. In the future we hope to earlier identify high-risk patients to improve treatment strategies and the outcome of RA patients.


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Brief Summary in Scientific Language

Hybrid Single-Photo-Emission Tomography (SPECT) and Positron Emission Tomography (PET) in combination with Magnet Resonance Imaging (MRI) are new imaging techniques, which allow for detection of malignant and inflammatory pathologies on a molecular basis. Both techniques are capable of depicting early inflammatory changes of the bone metabolism (SPECT) and soft tissue metabolism (PET) of finger joints in RA with high resolution. The purpose of this study is to compare findings from PET, SPECT and simultaneously acquired MRI of the clinical dominant hand in patients with RA under disease modifying antirheumatic drug therapy. Evaluation of this functional information might contribute to the understanding of the pathogenesis of RA on a molecular level. Hybrid imaging techniques are promising to be beneficial for early disease detection because changes of metabolism might be already present prior to visibilty of structural changes on MRI scans. In the future hybrid imaging techniques could add to an earlier detection of high-risk patients, improve treatment strategies and the outcome of RA patients.


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Organizational Data

  •   DRKS00003317
  •   2011/11/09
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  •   yes
  •   Approved
  •   3352, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   PET-MRI and SPECT of the clinical dominant hand of patients with newly diagnosed, therapy naiv rheumatoid arthritis prior and after 6 month antirheumatic treatment.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Extent of inflammatory joint changes in hybrid MR-PET and -SPECT on follow-up (6 month under antirheumatic treatment).

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Secondary Outcome

Correlation of structural joint pathologies (synovitis, bone marrow edema and erosions) and metabolic joint pathologies seen in PET and SPECT.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2012/01/05
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

New diagnosed rheumatoid arthritis according to the 2010 ACR/EULAR criteria, disease duration < 6 month, inflammatory involvement of at least one metacarpophalangeal joint or at least one proximal interphalangeal joint

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Exclusion Criteria

1) Present malignant disease or history of malignant disease in the last five years (not basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
2) History of any kind of severe cardiac disease (e.g. decompensated heart insufficency, history of myocardial infarction in the last 12 month, unstable angina pectoris or unregulated hypertension).
3) Severe pulmonary disorder.
4) History of immunodeficiency syndroms (HIV or other) or any rheumatic disease (if not RA) or any demyelinating CNS disease (e.g. MS)
5) History of live vaccination in the past 4 weeks prior to screening. 6) Intraarticular injections in in joints of the surveyed hand (< 4 weeks prior to screening). 7) Any kind of acute or chronic infection (e.g. Hepatitis A,B,C) or predisposition for an infection (e.g. ulcera, diabetes mellitus). 8) Renal disorders (Kreatinin 175 µmol/l, GFR < 30 mg/dl) 9) Zirrhosis or fibrosis of the liver or inadequate liver function. 10) Psychiatric disorders if limting the understanding of participatance in this study 11) Breast feading or Pregnancy. 12) General contradictions against MRI examinations (e.g. implanted cardiac pacemaker/ defibrillator, claustrophobia)

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Addresses

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    • Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie
    • Mr.  Prof. Dr. med.  Axel  Scherer 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie
    • Mr.  Prof. Dr. med.  Axel  Scherer 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf Klinik für Endokrinologie, Diabetologie und Rheumatologie
    • Mr.  PD Dr. med.  Benedikt  Ostendorf 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.