Amyotrophic Lateral SclerosisPhase 1NCT00563537
Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
A Phase 1 study testing 18F-X PET SCAN in people with Amyotrophic Lateral Sclerosis and Bulbar Disease, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Bulbar Disease, Spinal Disease
- What is being tested?
- 18F-X PET SCAN
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Nucléaire et Ultrasons - Hôpital Bretonneau
Tours, Centre-Val de Loire, 37044
Caroline PRUNIER, MD
Julien PRALINE, MD
About this study
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.
Read the 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.
- Being tested
- 18F-X PET SCAN
- Keywords
- neurology, sclerosis, imaging, tomography
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Spinal Diseases, Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-X PET SCANRadiation
18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 18F-X PET Scan imaging Receives: Radiation: 18F-X PET SCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion period
Secondary outcomes (2)
Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS
Measured: inclusion period
Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis
Measured: inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJan 2007
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Denis GUILLOTEAU, PHD, Study director, Service de médecine nucléaire in Vitro - CHRU TOURSPhilippe CORCIA, MD, Principal investigator, Service de Neurologie - CHRU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563537
- Sponsor's protocol ID
- PHRC05-PC / SLA
- Status last verified
- Mar 2010
- First submitted
- 22 Nov 2007
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15850659Banati RB. Visualising microglial activation in vivo. Glia. 2002 Nov;40(2):206-217. doi: 10.1002/glia.10144.
PubMed 12379908Banati 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.
PubMed 11050032Zhang 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.
PubMed 17978354Zhang 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.
PubMed 15084121Corcia 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.
PubMed 23300829
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00563537
- Acronym / sponsor ID
- PHRC05-PC / SLA
- Keywords
- neurology, sclerosis, imaging, tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2010 (estimated)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: 18F-X PET SCAN18F-X PET Scan imaging |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-X PET SCAN18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq) | Radiation | 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
- Background: PubMed 15850659Kassiou 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.
- Background: PubMed 12379908Banati RB. Visualising microglial activation in vivo. Glia. 2002 Nov;40(2):206-217. doi: 10.1002/glia.10144.
- Results publication: PubMed 11050032Banati 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 publication: PubMed 17978354Zhang 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 publication: PubMed 15084121Zhang 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.
- Derived from this study: PubMed 23300829Corcia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis GUILLOTEAU, PHD study director
Service de médecine nucléaire in Vitro - CHRU TOURS
Philippe CORCIA, MD principal investigator
Service de Neurologie - CHRU Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-X PET SCAN in people with Amyotrophic Lateral Sclerosis and Bulbar Disease, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine ROUSSEL ((33) 2.47.47. 97.89, roussel@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563537, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2010.