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临床试验/NCT04870645
NCT04870645已完成不适用

Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Contrast to Noise Ratio

研究概览

简要总结

This clinical trial studies the different types of investigational imaging techniques called sequences during magnetic resonance imaging (MRI) of the head before and after radiation therapy in patients with cancer that has spread to the brain (intracranial metastases). This clinical trial also compares these new techniques with standard MRI imaging to see if sequences provide better images. Diagnostic procedures, such as MRI, may help find and diagnose solid organ cancer and find out how far the disease has spread.

详细描述

PRIMARY OBJECTIVES:

I. Conspicuity:

Ia. To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline. (Quantitative MRI) Ib. To assess the conspicuity (CNR) of chemical exchange saturation transfer (CEST) imaging at detecting brain metastases at baseline. (CEST MRI) Ic. To assess the conspicuity (CNR) of advances in difference equations (Adv Diff) at detecting brain metastases at baseline. (Multiple B Value Diffusion Imaging [Adv Diff]) Id. To assess the conspicuity of gradient- and spin-echo (GESE) dynamic susceptibility contrast (DSC) and standard Gradient Echo (GE) DSC at detecting brain metastases at baseline. (GESE DSC perfusion imaging)

SECONDARY OBJECTIVES:

I. Conspicuity:

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

入选标准

  • An adult patient with pathology-proven solid organ cancer
  • MRI of the brain with contrast, positive for at least one intra-axial metastatic lesion greater than 5 mm
  • Planned treatment with stereotactic radiation

排除标准

  • Contraindication to MR imaging
  • 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
  • Patients less than 18 years of age will be excluded

研究组 & 干预措施

Diagnostic (advanced MRI)

Experimental

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

干预措施: Advanced Magnetic Resonance Imaging (Procedure)

Diagnostic (advanced MRI)

Experimental

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

干预措施: Conventional Magnetic Resonance Imaging (Procedure)

Diagnostic (advanced MRI)

Experimental

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

干预措施: Gadolinium-Chelate (Drug)

Diagnostic (advanced MRI)

Experimental

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

干预措施: Iopamidol (Drug)

结局指标

主要结局

Contrast to Noise Ratio

时间窗: Participants enrolled in the study were followed for variable amounts of times (up to 2 years and 4 months) from the date of their enrollment and baseline imaging

Contrast enhancement compared to baseline and normalized to background noise

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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