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

Sponsor

University Hospital, Tours (Other)

Overall Status

Unknown status

CT.gov ID

NCT00563537

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2007

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

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. [Inclusion period]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau	Tours	Region Centre	France	37044

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