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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00563537
Enrollment
30
Registered
2007-11-26
Start date
2007-01-31
Completion date
2010-12-31
Last updated
2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Bulbar Disease, Spinal Disease

Keywords

neurology, sclerosis, imaging, tomography

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.

Interventions

RADIATION18F-X PET SCAN

18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALSinclusion period
Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosisinclusion period

Countries

France

Contacts

Primary ContactCatherine ROUSSEL
roussel@med.univ-tours.fr(33) 2.47.47. 97.89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026