Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
|ClinicalTrials.gov Identifier: NCT00563537|
Recruitment Status : Unknown
Verified March 2010 by University Hospital, Tours.
Recruitment status was: Recruiting
First Posted : November 26, 2007
Last Update Posted : March 19, 2010
|First Submitted Date ICMJE||November 22, 2007|
|First Posted Date ICMJE||November 26, 2007|
|Last Update Posted Date||March 19, 2010|
|Study Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Quantitative in vivo-imaging of 18F-X microglial binding site as a mesure of disease activity followed up by non invasive quantification of patients using imaging modality. [ Time Frame: Inclusion period ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00563537 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis|
|Official Title ICMJE||Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis|
PET imaging of activated microglia offers a tool of investigation of a range of brain diseases where neuroinflammation is a component.
Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult.
This study was designed to explore the feasibility of molecular imaging modality by Positron Emission Tomography using 18F-X as an in vivo marker of activated microglia for the assessment of neuroinflammation in amyotrophic lateral sclerosis.
PET may help in the diagnosis of the disease and, further, may allow assessment of the efficacy of antiinflammatory treatment.
18F-X PET will be carried out requiring arterial sampling in 2 patients suffering from ALS and 2 normal subjects in order to evaluate the 18F-X quantification.
Then simplified PET using 18F-X will be carried out in 13 patients and 13 normal subjects.
Binding potential maps showing specific binding of 18f-X will be generated for each subject.
Regional binding potential values will be calculated for anatomically defined regions of interest after coregistration to and special transformation into the subject's own MRI.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Intervention ICMJE||Radiation: 18F-X PET SCAN
18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
|Study Arms||Experimental: 1
18F-X PET Scan imaging
Intervention: Radiation: 18F-X PET SCAN
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||December 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||40 Years to 70 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00563537|
|Other Study ID Numbers ICMJE||PHRC05-PC / SLA|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||University Hospital, Tours|
|Study Sponsor ICMJE||University Hospital, Tours|
|Collaborators ICMJE||Not Provided|
|PRS Account||University Hospital, Tours|
|Verification Date||March 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP