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

Primary Purpose

Amyotrophic Lateral Sclerosis, Bulbar Disease, Spinal Disease

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

18F-X PET SCAN

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis focused on measuring neurology, sclerosis, imaging, tomography

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Service de Médecine Nucléaire et Ultrasons - Hôpital BretonneauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

18F-X PET Scan imaging

Outcomes

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.

Secondary Outcome Measures

Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS

Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis

Full Information

NCT ID

NCT00563537

First Posted

November 22, 2007

Last Updated

March 18, 2010

Sponsor

University Hospital, Tours

1. Study Identification

Unique Protocol Identification Number

NCT00563537

Brief Title

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

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Tours

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Bulbar Disease, Spinal Disease

Keywords

neurology, sclerosis, imaging, tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

18F-X PET Scan imaging

Intervention Type

Radiation

Intervention Name(s)

18F-X PET SCAN

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS

Time Frame

inclusion period

Title

Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis

Time Frame

inclusion period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine ROUSSEL

Phone

(33) 2.47.47. 97.89

roussel@med.univ-tours.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denis GUILLOTEAU, PHD

Organizational Affiliation

Service de médecine nucléaire in Vitro - CHRU TOURS

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Philippe CORCIA, MD

Organizational Affiliation

Service de Neurologie - CHRU Tours

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau

City

Tours

State/Province

Region Centre

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline PRUNIER, MD

First Name & Middle Initial & Last Name & Degree

Julien PRALINE, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15850659

Citation

Kassiou M, Meikle SR, Banati RB. Ligands for peripheral benzodiazepine binding sites in glial cells. Brain Res Brain Res Rev. 2005 Apr;48(2):207-10. doi: 10.1016/j.brainresrev.2004.12.010. Epub 2005 Jan 22.

Results Reference

background

PubMed Identifier

12379908

Citation

Banati RB. Visualising microglial activation in vivo. Glia. 2002 Nov;40(2):206-217. doi: 10.1002/glia.10144.

Results Reference

background

PubMed Identifier

11050032

Citation

Banati RB, Newcombe J, Gunn RN, Cagnin A, Turkheimer F, Heppner F, Price G, Wegner F, Giovannoni G, Miller DH, Perkin GD, Smith T, Hewson AK, Bydder G, Kreutzberg GW, Jones T, Cuzner ML, Myers R. The peripheral benzodiazepine binding site in the brain in multiple sclerosis: quantitative in vivo imaging of microglia as a measure of disease activity. Brain. 2000 Nov;123 ( Pt 11):2321-37. doi: 10.1093/brain/123.11.2321.

Results Reference

result

PubMed Identifier

17978354

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.

Results Reference

result

PubMed Identifier

15084121

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.

Results Reference

result

PubMed Identifier

23300829

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.

Results Reference

derived

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

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