A Monocentric, Controlled, Open Label, Phase I, First-in-human Trial to Investigate the Regional Distribution of [18F]RoSMA-18-d6 in the Brain and Spinal Cord to Assess Cannabinoid Type 2 Receptor (CB2R) Expression in Healthy Volunteers and Patients With Amyotrophic Lateral Sclerosis (ALS) by Positron Emission Tomography (PET)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
- Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ?
- Does the amount of this protein change during the course of the disease?
- Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ALS patients
ALS patients will get two imaging sessions with [18F]RoSMA-18-d6 PET/CT and MRI-scans one year apart
干预措施: [18F]-RoSMA-18-d6 (Drug)
Healthy volunteers
Healthy volunteers will get only one pair of [18F]RoSMA-18-d6 PET/CT and MRI scans
干预措施: [18F]-RoSMA-18-d6 (Drug)
结局指标
主要结局
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
时间窗: 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
次要结局
- [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)
研究者
Markus Weber
Prof. Dr. med.
Cantonal Hospital of St. Gallen