Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1)
研究概览
简要总结
This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis [RN]). Radiation therapy is often used in the treatment of brain tumors. Radiation treatment response can be difficult to assess and is usually done using conventional MRI, which uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Current imaging techniques have a limited ability to identify the difference between recurrent brain tumor and RN due to their similar appearance on conventional MRI and overlapping clinical presentation. This makes it hard for doctors to plan the best way to treat these tumors. DR-CSI is a new MRI technique with the potential to detect microscopic tissue components with different characteristics. Sodium imaging is an MRI technique that estimates the total sodium concentration in the obtained images. It may be able to identify the small structures within the tissue of brain tumors. Advanced MRI techniques like DR-CSI and sodium imaging may be effective in identifying the difference between recurrent brain tumors and RN.
详细描述
PRIMARY OBJECTIVES:
I. Develop and validate dual-nuclei microstructural MRI biomarkers to differentiate between recurrent brain metastasis (rBM) and RN.
II. Investigate longitudinal microstructural changes following stereotactic radiosurgery (SRS) treatment and predict clinical outcome.
OUTLINE: Patients are assigned to 1 of 2 aims.
AIM 1: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to standard of care (SOC) surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Diagnosed with metastatic brain tumor
- •AIM 1: Scheduled for surgical resection or tissue biopsy +/- laser interstitial thermal therapy (LITT)
- •AIM 2: Scheduled for SRS treatment
排除标准
- •Patients with contraindications to MRI, severe renal impairment
- •Patients with evidence of disseminated leptomeningeal disease
研究组 & 干预措施
Aim 1 (advanced MRI)
Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
干预措施: Advanced Magnetic Resonance Imaging (Procedure)
Aim 1 (advanced MRI)
Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
干预措施: Biospecimen Collection (Procedure)
Aim 1 (advanced MRI)
Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Aim 2 (advanced MRI)
Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.
干预措施: Advanced Magnetic Resonance Imaging (Procedure)
Aim 2 (advanced MRI)
Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1)
时间窗: At time of advanced magnetic resonance imaging: Baseline
Will compute the diffusion-relaxation (DR) spectra and total sodium concentration (TSC) within biopsy regions of interest and use Student t-test or Mann-Whitney U test, depending on the data distribution, to compare imaging features between rBM and RN groups. Specifically, for DR spectra, the test statistic at each spectral location will be used to identify spectral components associated viable tumor and treatment effect. The information will subsequently be used to partition the voxel-wise DR spectra and compute voxel-wise "viable tumor" and "treatment effect" fraction maps. Multivariate logistic regression models will assess the predictive value of the imaging biomarkers, including DR-correlation spectrum imaging (CSI) spectral components and TSC. Receiver operating characteristic (ROC) analysis will evaluate diagnostic performance, calculating area under the curve, sensitivity, specificity, and optimal cutoff values for differentiating rBM and RN.
Stereotacic imaging-guided biopsies and correlation with tissue quantifications (Aim 1)
时间窗: Up to completion of surgery
Will prospectively acquire DR-CSI and sodium imaging-guided biopsies of tumor tissue in regions with different imaging characteristics. Pearson or Spearman correlations will be computed between imaging features and quantitative histological measures of cellularity, extracellular fraction, and percentages of tumor and necrosis.
Early imaging changes as predictors of clinical outcomes (Aim 2)
时间窗: At baseline and 2 weeks, 3 months, and 6 months post-stereotactic radiosurgery (SRS)
Will compute DR-CSI spectral components and TSC at each time point. Repeated measure analysis of variance will assess imaging changes over time. Will also plot trajectories of imaging biomarkers to visualize temporal patterns. Multivariate logistic regression models will evaluate early imaging changes (2 weeks and 3 months) as predictors of 6-month outcomes. Lesions will be stratified into responders (complete or partial response) and non-responders (stable disease or progression) based on their Response Assessment in Neuro-Oncology Brain Metastases assessment at 6-month post-SRS. ROC curves will assess the predictive performance of early microstructural imaging changes and the multivariate model. Primary tumor type will be included as a covariate in analyses.
次要结局
未报告次要终点