Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Registration Number
- NCT05880563
- Lead Sponsor
- Markus Weber
- Brief Summary
This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance \[18F\]-RoSMA-18-d6 are being carried out for the first time.
This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals.
The following questions will be answered by this clinical trial.
1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ?
2. Does the amount of this protein change during the course of the disease?
3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALS patients [18F]-RoSMA-18-d6 ALS patients will get two imaging sessions with \[18F\]RoSMA-18-d6 PET/CT and MRI-scans one year apart Healthy volunteers [18F]-RoSMA-18-d6 Healthy volunteers will get only one pair of \[18F\]RoSMA-18-d6 PET/CT and MRI scans
- Primary Outcome Measures
Name Time Method Difference of [18F]RoSMA-18-d6 uptake in the brain and spinal cord between ALS patients (at baseline and day 360) and healthy, age- and gender-matched subjects, as assessed by PET and MRI to allow morphological mapping Baseline and day 360 Voxelwise maps of the total distribution volume (VT; ml g-
1) of \[18F\]RoSMA-18-d6 are calculated using the Logan method (42) as well as compartmental modelling i.e., the evaluation of the microparameters of a two-tissue reversible binding model (43) Mean parametric maps for brain are calculated for the baseline and follow-up conditions in the controls and ALS patient groups. Furthermore, standardized uptake values (SUV) regarding tracer uptake after 15, 30, 60 and - if available - 90 minutes will be determined
- Secondary Outcome Measures
Name Time Method [18F]RoSMA-18-d6 uptake at month twelve (360 days) compared with uptake at baseline as assessed by PET/CT of the brain and spinal cord. Baseline and day 360 Correlation of [18F]RoSMA-18-d6 uptake with corresponding respiratory function measurements (FVC, SNIP) from baseline to day 360. Baseline and day 360 Correlation of [18F]RoSMA-18-d6 uptake with corresponding ALSFRS-Score from baseline to day 360. Baseline and day 360 Correlation of the change of [18F]RoSMA-18-d6 endpoints (Δ-CB2R; baseline to day 360) with corresponding changes of the-ECAS score Baseline and day 360
Trial Locations
- Locations (1)
Muskelzentrum/ALS-Clinic, Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Muskelzentrum/ALS-Clinic, Kantonsspital St. Gallen🇨🇭St. Gallen, Switzerland