Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Differences between peritumoral and normal brain
研究概览
简要总结
This trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To use 3-dimensional (3D) quantitative mapping to determine whether differences in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere at baseline.
II. To use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment.
SECONDARY OBJECTIVES:
I. Determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment.
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
- •At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
- •Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
- •Patient is able to understand and give own consent to participate in the study
排除标准
- •Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
- •Contraindication or history of allergy to Gadolinium-based (gadobutrol [Gadovist], gadobenate dimeglumine (Multihance]) intravenous contrast
- •Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
- •Prior partial (greater than 50%) or gross total resection of primary tumor
- •Prior chemotherapy or radiation treatment to brain
研究组 & 干预措施
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
干预措施: Gadobenate Dimeglumine (Drug)
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
干预措施: Gadobutrol (Drug)
Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Differences between peritumoral and normal brain
时间窗: Baseline up to 120 days
Will use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment. The regions of interest drawn on measured magnetic resonance (MR) spin parameter and MR perfusion parameter values will be grouped according to time point (pre- or post-treatment) and area (peritumoral, tumoral, and normal brain in the contralateral hemisphere). Descriptive statistics and boxplots of these measurements, paired differences between areas and paired differences between time points will be calculated. Will calculate 95% confidence intervals around the mean paired change between area differences at baseline and post-treatment.
Differences in T2 spin parameters
时间窗: Baseline
Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
次要结局
- Usefulness of T2 values in distinguishing non-enhancing components of the tumor(Up to 120 days)
- Quantification of T1 and proton density (PD) parameters(Baseline up to 120 days)
- Post-contrast T1 spin parameters with perfusion characteristics(Up to 120 days)
- Differences in measured perfusion parameters before and after treatment.(Baseline up to 120 days)