Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Average Duration of MRF Sequence - Feasibility
研究概览
简要总结
This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.
详细描述
Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.
Specific Aim 2: Characterize the MRF signature of low-grade gliomas
Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.
Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.
Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing MRI evaluation of the brain
- •NF1 status will be determined by clinical exam or genetic testing
- •NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1
- •Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans
排除标准
- •History of mental retardation unrelated to brain tumor
- •Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)
- •History of cerebrovascular accident (stroke)
- •Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
- •Major psychiatric diagnosis prior to neuro-oncological diagnosis
结局指标
主要结局
Average Duration of MRF Sequence - Feasibility
时间窗: Up to 1 year
The duration of MRF sequence in minutes will be recorded as a measure of feasibility
次要结局
- Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue(Up to 1 year)
- Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)(Up to 1 year)
- Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue(Up to 1 year)
- Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans(Up to 1 year)