Comparison of MRI Sequences T1 and T2 * Cerebral Perfusion to Aid in the Diagnosis and Evaluation of Brain Therapeutic Response With Chemotherapy or Targeted Therapy(s) Lesion(s) in Patients Treated and Followed for a Pulmonary Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparing different parameters evaluated in T1 and T2 * perfusion
研究概览
简要总结
This study therefore aims to assess current treatment recommended by scientific societies [ 6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg [ 14 ] . Sequences infusion different from one center to the other made : some use the infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to use one or the other of these sequences.
No examination is added for the purposes of protocol. Indications for MRI and the number and timing of MRI checks under this protocol are consistent with what is done in practice . The used type of gadolinium and the injected dose will be identical for both sequences infusion . The assessment shall not in any case the contrast but the interpretation of the sequence itself. Special procedures monitoring implemented embodiment correspond to the two sequences instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI of the first control , in order to compare their effectiveness
详细描述
Eligibility criteria:
- Major Patients
- Addressed MRI for initial assessment of brain metastases
- At a suspicion of one or more brain metastases in the brain scanner routine screening
- Follow for lung cancer histologically documented
- In the Thoracic Oncology Service Professor Lafitte (contact: Dr Cortot)
- To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered
- Be socially insured
Main Outcomes measures:
Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 * perfusion during the initial assessment for the diagnosis of maximal tumor response evaluated at 1 year
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
- •Major Patients
- •Addressed to MRI for initial assessment of brain metastases
- •At a suspicion of one or more brain metastases in the brain scanner routine screening
- •Followed for lung cancer histologically documented in the Thoracic Oncology Service of Professor Lafitte (contact: Dr Cortot)
- •To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered
- •Be socially insured-
排除标准
- •Absolute contraindication to MRI (pacemaker, implantable pacemaker, metallic foreign body intraorbital)
- •Patients minors under guardianship / curatorship
- •Patients with impaired judgment skills or unable to receive information
- •Pregnant Women
- •Patients for which lesions are not compatible with lung metastases
- •Patients with brain metastases or already known and explored MRI
- •Patients for whom treatment by surgical excision of brain metastases is considered
研究组 & 干预措施
MRI T1 T2 sequences
comparison of perfusion sequences T1 T2 in patients with brain metastase cancer
干预措施: MRI T1 T2 sequences (Other)
结局指标
主要结局
Comparing different parameters evaluated in T1 and T2 * perfusion
时间窗: 3 years
Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 \* perfusion during the initial assessment for the diagnosis of maximal tumor
次要结局
- Evaluation tumor response(1 year)
- Radiological progression-free survival(1 year)
- Survival without neurological signs(1 year)