Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Contrast-to-noise Ratio (CNR)
研究概览
简要总结
This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.
SECONDARY OBJECTIVE:
I. To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.
EXPLORATORY OBJECTIVES:
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
- •Adult patients must meet one set of inclusion criteria:
- •Newly identified and untreated central nervous system glioma or metastasis of at least 5 mm or greater in size
- •Suspected central nervous system neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon or a radiation oncology that a lesion exists that is most likely either a glioma or a metastasis
- •Patients with suspected brain metastasis must also have a history of solid organ malignancy
- •History of central nervous system glioma or metastasis treated with surgery, radiation, chemotherapy, or immunotherapy with new or increasing signal on MR imaging that is suspicious for progressive disease (treatment failure)
- •Suspected recurrent neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon, radiation oncologist, or neuro-oncologist that lesion behavior is suspicious for recurrent disease
排除标准
- •Contraindication to MR imaging
- •Absolute or relative contra-indication to 3T MRI due to metallic foreign bodies and devices and/or other conditions that are not MR safe, which include implants with unknown behavior in 3T MRI as well as:
- •Electronically, magnetically, and mechanically activated implants
- •Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
- •Metallic splinters in the eye
- •Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
- •Cochlear implants
- •Other pacemakers, e.g., for the carotid sinus
- •Insulin pumps and nerve stimulators
- •Non-MR safe lead wires
- •Prosthetic heart valves (if dehiscence is suspected)
- •Non-ferromagnetic stapedial implants
- •Pregnancy
- •Claustrophobia that does not readily respond to oral medication
- •Known allergy to gadolinium-based contrast agents
- •Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
- •Interval treatment with radiation or surgery between the diagnostic MRI lesion identification and planned study MRI
研究组 & 干预措施
Diagnostic (7T MRI)
Patients undergo 7T MRI over 60 minutes.
干预措施: 7 Tesla Magnetic Resonance Imaging (Procedure)
Diagnostic (7T MRI)
Patients undergo 7T MRI over 60 minutes.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Contrast-to-noise Ratio (CNR)
时间窗: 1 year
Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.
次要结局
未报告次要终点