Clinical trial NCT00563537: Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
Official title: Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Bulbar Disease
Spinal Disease
Keywords: neurology
sclerosis
imaging
tomography
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Inclusion period
Secondary outcomes:
measure: Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS
timeFrame: inclusion period
measure: Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis
timeFrame: inclusion period
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau
state: Region Centre
Study officials:
affiliation: Service de médecine nucléaire in Vitro - CHRU TOURS
name: Denis GUILLOTEAU, PHD
role: STUDY_DIRECTOR
affiliation: Service de Neurologie - CHRU Tours
name: Philippe CORCIA, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zhang MR, Kumata K, Maeda J, Yanamoto K, Hatori A, Okada M, Higuchi M, Obayashi S, Suhara T, Suzuki K. 11C-AC-5216: a novel PET ligand for peripheral benzodiazepine receptors in the primate brain. J Nucl Med. 2007 Nov;48(11):1853-61. doi: 10.2967/jnumed.107.043505.
citation: Zhang MR, Maeda J, Ogawa M, Noguchi J, Ito T, Yoshida Y, Okauchi T, Obayashi S, Suhara T, Suzuki K. Development of a new radioligand, N-(5-fluoro-2-phenoxyphenyl)-N-(2-[18F]fluoroethyl-5-methoxybenzyl)acetamide, for pet imaging of peripheral benzodiazepine receptor in primate brain. J Med Chem. 2004 Apr 22;47(9):2228-35. doi: 10.1021/jm0304919.
citation: Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. 2012;7(12):e52941. doi: 10.1371/journal.pone.0052941. Epub 2012 Dec 31.