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

March 18, 2010 updated by: University Hospital, Tours

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Region Centre
      • Tours, Region Centre, France, 37044
        • Recruiting
        • Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau
        • Sub-Investigator:
          • Caroline PRUNIER, MD
        • Sub-Investigator:
          • Julien PRALINE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: Inclusion period
Inclusion period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 22, 2007

First Submitted That Met QC Criteria

November 22, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC05-PC / SLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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