ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence
研究概览
简要总结
Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment.
The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment
详细描述
The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.
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
- •Brain metastasis from histologically proven tumor
- •GK treatment within 4 month prior to the inclusion
- •Lesions suspected of progression/ radionecrosis :
- •i.e.≥ 25% of the size progression
- •Lesion size: gadolinium enhanced part of the tumour ≥1 cm
排除标准
- •Pregnancy
- •Medical history of primitive brain tumour
- •MRI incompatibility/ medical history of contrast agent allergy
- •Claustrophobia
- •Patient unable to consent
- •Epilepsia/recent stroke
- •Patients participating in other studies
- •Patients without health care insurance
结局指标
主要结局
Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence
时间窗: Evolution between Baseline MRI, 1 and 6 month follow up MRI
Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.
次要结局
- ASL Perfusion: Cerebral blood flow measurements(Baseline MRI, 1 and 6 month follow up MRI)
- Morphological analysis of the lesions(Baseline MRI, 1 and 6 month follow-up MRI)
- Interreader correlation(Baseline MRI, 1 and 6 month follow-up MRI)