Optimization and Application of Hybrid Intravoxel Incoherent Motion – Diffusion Kurtosis Imaging in the Evaluation of Brain Tumours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- IVIM:
研究概览
简要总结
The study aimed to optimize a non-invasive, non-contrast IVIM-DKI sequence and evaluate its effectiveness in the evaluation of brain tumours.
The study will be performed in 2 Phases.
In Phase I, optimization of the protocol will be performed on patients (who may or may not have brain tumours) who were referred for anMRI contrast study with a sample size of 27.
In Phase II , an optimized protocol will be used to evaluate brain tumours. This phase has 2 objectives; one is to evaluate the freshly diagnosed brain tumours prior to treatment with sample size of 33. Another one is to distinguish the recurrent/residual lesion from the post-treatment changes with the sample size time-bound.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase I: Patients referred for contrast-enhanced MRI brain scan Phase II: Patients with brain tumours who have not undergone surgery or treatment for tumours Patient with brain tumours post-surgery or post-chemo/radiotherapy.
排除标准
- •Phase I & II: Pregnant patient Uncooperative patients Patients contraindicated for MRI.
结局指标
主要结局
IVIM:
时间窗: At the time of scan
D: True diffusion coefficient
时间窗: At the time of scan
D star: Pseudo diffusion coefficient
时间窗: At the time of scan
f: Perfusion fraction
时间窗: At the time of scan
DDC: Distributed diffusion coefficient
时间窗: At the time of scan
Alpha: Heterogeneity Index
时间窗: At the time of scan
MK: Mean Kurtosis
时间窗: At the time of scan
MD: Mean Diffusivity
时间窗: At the time of scan
DSC:
时间窗: At the time of scan
CBV: Cerebral Blood Volume
时间窗: At the time of scan
CBF: Cerebral Blood Flow
时间窗: At the time of scan
MTT: Mean Transit Time
时间窗: At the time of scan
TTP: Time to Peak
时间窗: At the time of scan
DWI:
时间窗: At the time of scan
ADC: Apparent Diffusion Coefficient
时间窗: At the time of scan
次要结局
- DDC, alpha and D compared against ADC value in classification of tumours(At the time of scan)
研究者
Abhijith S
Manipal College of Health Professions, MAHE