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

R

Regional University Hospital Center (CHRU)

Status and phase

Unknown
Phase 1

Conditions

Bulbar Disease
Spinal Disease
Amyotrophic Lateral Sclerosis

Treatments

Radiation: 18F-X PET SCAN

Study type

Interventional

Funder types

Other

Identifiers

NCT00563537
PHRC05-PC / SLA

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

1
Experimental group
Description:
18F-X PET Scan imaging
Treatment:
Radiation: 18F-X PET SCAN

Trial contacts and locations

1

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Central trial contact

Catherine ROUSSEL

Data sourced from clinicaltrials.gov

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