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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
History of Changes
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
Bulbar Disease
Spinal Disease
 Radiation: 18F-X PET SCAN
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
Arms Assigned Interventions
Experimental: 1
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563537

Contacts
Contact: Catherine ROUSSEL (33) 2.47.47. 97.89 roussel@med.univ-tours.fr

Locations
France
Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau Recruiting
Tours, Region Centre, France, 37044
Sub-Investigator: Caroline PRUNIER, MD            
Sub-Investigator: Julien PRALINE, MD            
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Denis GUILLOTEAU, PHD Service de médecine nucléaire in Vitro - CHRU TOURS
Principal Investigator: Philippe CORCIA, MD Service de Neurologie - CHRU Tours
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00563537     History of Changes
Other Study ID Numbers: PHRC05-PC / SLA
Study First Received: November 22, 2007
Last Updated: March 18, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
neurology
sclerosis
imaging
tomography

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Spinal Diseases
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
 TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013