Quantitative High-Field Magnetic Resonance Imaging (MRI) for Assessing Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Volume transfer constant (Ktrans), as measured by DCE-MRI
研究概览
简要总结
This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.
详细描述
PRIMARY OBJECTIVES:
I. To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).
OUTLINE:
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.
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
- •Patients must sign an Institutional Review Board (IRB)-approved informed consent document
- •Patients must have been diagnosed with one of the following:
- •Primary brain tumor (glioma, GBM etc); or
- •Up to 10 brain metastases
- •Patients must have been diagnosed with 1-4 brain metastases
- •At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane
- •Patients must be scheduled to undergo standard brain cancer interventions:
- •Chemotherapy or targeted antiangiogenic therapy, in the case of primary brain tumor; or
- •Stereotaxic radiotherapy (SRS) or whole brain radiotherapy (WBRT), in the case of brain metastases.
- •Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be modified to also include pulse sequences with are for research only)
排除标准
- •Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic).
- •Patients who are scheduled to receive a 1.5T MRI exam
- •Patients incapable of giving informed written consent, due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders.
- •Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on the study
研究组 & 干预措施
Diagnostic (hybrid MRI)
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.
干预措施: diffusion-weighted magnetic resonance imaging (Procedure)
Diagnostic (hybrid MRI)
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.
干预措施: chemical exchange saturation transfer magnetic resonance imaging (Procedure)
Diagnostic (hybrid MRI)
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.
干预措施: dynamic contrast-enhanced magnetic resonance imaging (Procedure)
Diagnostic (hybrid MRI)
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.
干预措施: dynamic susceptibility contrast-enhanced magnetic resonance imaging (Procedure)
结局指标
主要结局
Volume transfer constant (Ktrans), as measured by DCE-MRI
时间窗: Baseline
The ability of pre-treatment estimates of Ktrans to predict objective tumor response by Response Evaluation Criteria in Solid Tumors or Macdonald criteria after therapy will be assessed using the proportional odds model.
次要结局
- Amide proton transfer asymmetry (APTasym) as measured by CEST(Baseline)
- Apparent diffusion coefficient (ADC), as measured by DW-MRI(Baseline)
- Plasma volume fraction (Vp), as measured by DCE-MRI(Baseline)
- Mean transit time (MTT), as measured by DSC-MRI(Baseline)
- Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI(Baseline)
- Cerebral blood volume (CBV), as measured by DSC-MRI(Baseline)
- Cerebral blood flow (CBF), as measured by DSC-MRI(Baseline)
研究者
Albert Attia
Assistant Professor of Radiation Oncology; Radiation Oncologist
Vanderbilt-Ingram Cancer Center