Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT03876002
Brief 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.
Study:
NCT03876002
Study Brief:
Protocol Section:
NCT03876002