Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
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|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis Bulbar Disease Spinal Disease||Radiation: 18F-X PET SCAN||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis|
|Study Start Date :||January 2007|
|Estimated Study Completion Date :||December 2010|
U.S. FDA Resources
18F-X PET Scan imaging
Radiation: 18F-X PET SCAN
18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
- 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 ]
- Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS [ Time Frame: inclusion period ]
- Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis [ Time Frame: inclusion period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563537
|Contact: Catherine ROUSSEL||(33) 2.47.47. firstname.lastname@example.org|
|Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau||Recruiting|
|Tours, Region Centre, France, 37044|
|Sub-Investigator: Caroline PRUNIER, MD|
|Sub-Investigator: Julien PRALINE, MD|
|Study Director:||Denis GUILLOTEAU, PHD||Service de médecine nucléaire in Vitro - CHRU TOURS|
|Principal Investigator:||Philippe CORCIA, MD||Service de Neurologie - CHRU Tours|