Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET
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|ClinicalTrials.gov Identifier: NCT03876002|
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Amyotrophic Lateral Sclerosis||Drug: [18F]PBR06||Phase 1|
The overall goal of this protocol is to evaluate microglial activation in the brain using [18F]PBR06 in patients with amyotrophic lateral sclerosis (ALS). The specific objectives are:
- To measure the dynamic uptake and washout of [18F]PBR06 (Peripheral benzodiazepine receptor-06) in brain using positron emission tomography (PET) in patients with ALS and healthy volunteers (HV).
- To evaluate test/retest reliability of the tracer binding parameters in patients with ALS and HV.
- To evaluate the correlation of [18F]PBR06 binding with ALS disease clinical severity (ALSFRS-R, upper motor neuron burden (UMNB) and Ashworth Score), clinical disease sub-categorization, and other clinical data.
- To perform kinetic modeling using plasma-based (metabolite corrected plasma concentration) or reference region based methods or simplified quantification methods to assess the ability of [18F]PBR06 PET to measure microglial activation in brain.
- To acquire safety data following injection of [18F]PBR06.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Microglial Activation Using the PET Imaging Ligand [18F]PBR06 in Patients With Amyotrophic Lateral Sclerosis Compared to Healthy Volunteers|
|Actual Study Start Date :||June 28, 2016|
|Actual Primary Completion Date :||February 7, 2018|
|Actual Study Completion Date :||February 7, 2018|
To perform kinetic modeling using plasma-based (metabolite corrected plasma concentration) or reference region based methods or simplified quantification methods to assess the ability of [18F]PBR06 PET to measure microglial activation in brain.
Subjects will undergo PET imaging using 1 single intravenous (IV) injection of [18F]PBR06, a PET radioligand for evaluation of microglial activation in the brain. PBR06 will be injected intravenously as a bolus at a dose of no more than 5.5mCi (millicurie).
- Time-activity data [ Time Frame: 1 year ]Time-activity data will be analyzed with 2-tissue compartment model, using the radiometabolite-corrected plasma input function. To correct the brain data for its vascular component, radioactivity in serial whole blood will be measured and then subtracted from the PET measurements. Non-invasive simple tissue ratio methods will also be evaluated.
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): NCT03876002
|United States, Connecticut|
|Molecular NeuroImaging, LLC|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||David Russell, M.D., Ph. D||Molecular NeuroImaging|