Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00563537
First received: November 22, 2007
Last updated: March 18, 2010
Last verified: March 2010

November 22, 2007
March 18, 2010
January 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00563537 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Amyotrophic Lateral Sclerosis
  • Bulbar Disease
  • Spinal Disease
Radiation: 18F-X PET SCAN
18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
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.
 
Recruiting
30
December 2010
Not Provided

Inclusion Criteria:

  • suffering from probable or definite form of amyotrophic lateral sclerosis according to El Escorial criteria. Spinal or bulbar site of the disease.
  • Information and signature of the written consent form
  • French Social Security registration

Exclusion Criteria:

  • family history of ALS
  • Riluzole treatment before the first PETscan.
  • Psychiatric disorders
  • Evolution of the disease older than 18 months
  • Antiinflammatory or antibiotic treatment in the last month
Both
40 Years to 70 Years
Yes
Contact: Catherine ROUSSEL (33) 2.47.47. 97.89 roussel@med.univ-tours.fr
France
 
NCT00563537
PHRC05-PC / SLA
Yes
University Hospital, Tours
University Hospital, Tours
Not Provided
Study Director: Denis GUILLOTEAU, PHD Service de médecine nucléaire in Vitro - CHRU TOURS
Principal Investigator: Philippe CORCIA, MD Service de Neurologie - CHRU Tours
University Hospital, Tours
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP