Accuracy of MR Perfusion Without and With Gadolinium at 3T in the Diagnosis of Patients With Suspected Recurrent High Grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Estimate the Receiver Operating Characteristic (ROC) curve
研究概览
简要总结
Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI can be performed with an injection of exogenous contrast using dynamic contrast enhancement (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be performed without contrast injection using arterial spin labeling (ASL) or intravoxel incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted contrast enhancement (DSC) perfusion is the most common technique used in clinical practice but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based techniques in differentiating recurrent tumour from radiation-induced brain injury in patients with known high grade glioma. The investigators will compare the accuracy of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI.
详细描述
The aim of this study is to evaluate the diagnostic accuracy of different MR perfusion methods in differentiating recurrent tumour from radiation-induced brain injury in patients with high grade gliomas. The investigators will evaluate perfusion methods which do not use an exogenous agent (ASL, IVIM) and methods which use gadolinium as a contrast agent (DSC-MRI, DCE-MRI).
A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI. The first T1 mapping method uses a Lock-Locker inversion-recovery acquisition (MOLLI) that measures apparent T1 (T1*). The second T1 mapping method uses a single-point, saturation-recovery acquisition that measures true T1 SMART1Map.
This study is a prospective study which will involve 50 patients.
Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study. Informed consent by the patient or a legal guardian or authorized representative of the patient will be obtained before enrollment.
Following enrollment, MR perfusion imaging (ASL, IVIM, DSC and DCE perfusion sequences) will be performed in addition to the routine neuronavigational sequence obtained fror re-operative/ therapy planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients enrolled must have:
- •Had a diagnosis of high grade glioma and had received chemoradiation
- •Developed a new lesion or an increase size of their treated lesion on follow-up MRI (either on post contrast T1W images or on FLAIR)
- •Karnofsky performance status (kps) score >70 (potential candidate for reresection of stereotactic radiation)
排除标准
- •Patients under 18 years of age
- •Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required).
- •Known or suspected allergies to gadolinium-based contrast agents.
- •Patients with chronic or acute renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), including acute renal insufficiency of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period.
- •General contraindications to MRI such as pacemaker or ferromagnetic implants.
- •Severe cardiovascular disease
- •Intractable seizures while on adequate anticonvulsant therapy (more than one seizure per month for the past 2 months)
- •Sickle-cell anaemia or other known hemoglobinopathies, or other forms of haemolytic anaemia
结局指标
主要结局
Estimate the Receiver Operating Characteristic (ROC) curve
时间窗: up to 22 months
Estimate the Receiver Operating Characteristic (ROC) curve for the assessment of the diagnostic accuracy of f, CBF, CBV, Cp and Ktrans, obtained from different MR perfusion acquisition methods for distinguishing recurrent tumour from radiation necrosis.
次要结局
- Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard(up to 22 months)