We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by University Hospital, Tours.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563537
First Posted: November 26, 2007
Last Update Posted: March 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Tours
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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. [ Time Frame: Inclusion period ]

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

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563537


Contacts
Contact: Catherine ROUSSEL (33) 2.47.47. 97.89 roussel@med.univ-tours.fr

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00563537     History of Changes
Other Study ID Numbers: PHRC05-PC / SLA
First Submitted: November 22, 2007
First Posted: November 26, 2007
Last Update Posted: March 19, 2010
Last Verified: March 2010

Keywords provided by University Hospital, Tours:
neurology
sclerosis
imaging
tomography

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Spinal Diseases
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Bone Diseases
Musculoskeletal Diseases