Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- ASMase activity measurement
研究概览
简要总结
The purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment. The patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours after the radiation is given. This study will evaluate if these changes can be seen and measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research exam which is similar to a standard MRI exam, with only a slight difference in the technical parameters used to acquire the images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Histologically proven cancer
- •Patients deemed clinically appropriate for radiation treatment as part of the standard care provided by their treating physician, and will receive either 24 Gy (one fraction) or 3 Gy x 10 fractions.
- •Life expectancy > 6 months
- •Age ≥ 18 years old.
排除标准
- •Pregnant patients
- •Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
- •Prior radiotherapy to the site of intended treatment
- •Patients with tumor involving brain or spinal cord
- •Platelet count <75,000/μl, HgB level <9 g/dl, WBC <3500/μl
- •Presence of metastases in the upper thoracic spine (in order to avoid DW- MRI parameter measurement variability due to cardiac motion)
- •Lesions <1.5 cm (to assure robust measurements)
- •Non-English speaking patients
结局指标
主要结局
ASMase activity measurement
时间窗: up to 18-24 hours after the first radiation treatment
For each serum ASMase activity measurement, we will use 3 technical assay replicates. Each of three replicates will be averaged. Then the post-treatment activity will be normalized (fraction) against its paired pre-treatment activity.
次要结局
- C16 serum ceramide levels(1 year)
- C18 serum ceramide levels(1 year)