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

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis; Bulbar Disease; Spinal Disease
• Interventions: Radiation: 18F-X PET SCAN

• Registration Number: NCT00563537
• Lead Sponsor: University Hospital, Tours

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-11-22
• Study First Submitted QC: 2007-11-22
• Study First Posted: 2007-11-26
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	18F-X PET SCAN	18F-X PET Scan imaging

Primary Outcome Measures

Name	Time	Method
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.	Inclusion period

Secondary Outcome Measures

Name	Time	Method
Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS	inclusion period
Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis	inclusion period

Trial Locations

Locations (1)

Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau; 🇫🇷 Tours, Region Centre, France