NCT03876002

Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET

Evaluation of Microglial Activation Using the PET Imaging Ligand [18F]PBR06 in Patients With Amyotrophic Lateral Sclerosis Compared to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Molecular NeuroImaging · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this protocol is to evaluate microglial activation in the brain using \[18F\]PBR06 in patients with amyotrophic lateral sclerosis (ALS).

Detailed description

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.

Conditions

• Healthy Volunteers
• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	[18F]PBR06	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).

Timeline

• Start date: 2016-06-28
• Primary completion: 2018-02-07
• Completion: 2018-02-07
• First posted: 2019-03-15
• Last updated: 2019-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study