Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion
研究概览
简要总结
This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.
详细描述
PRIMARY OBJECTIVES:
I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.
OUTLINE:
Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple lesions from solid tumors on clinical MRI diagnosing the brain metastases may be treated with either WBRT or SRS if clinically indicated at the time of presentation but not both
- •Karnofsky performance status (KPS) >= 70
- •Patients presenting with brain metastases from a newly diagnosed cancer may have systemic disease (brain disease at the time of initial cancer diagnosis)
- •Patients with a history of cancer, but newly diagnosed brain metastases must have clinically stable systemic disease
- •If a biopsy is performed, the patient has to be at least 1 week post-biopsy
- •The patient must be able to commit to diffusion-weighted magnetic resonance (MR) imaging, diffusion tensor imaging (DTI), and chemical shift imaging (CSI) prior to treatment, after the first week of treatment, and 7-11 days after the completion of treatment at the Magnetic Resonance Research Center (MRRC)
- •Patients undergoing SRS without WBRT must be able to commit to diffusion-weighted MR imaging, DTI, and CSI prior to treatment, and 7-11 days after the completion of the SRS treatment at the MRRC
- •The patient must also be able to commit to post-treatment follow-up visits at Montefiore Medical Center involving serial MR imaging; the follow-up visits are to occur bimonthly for 6 months and then every 6 months until death
排除标准
- •Any medical condition, which would make the imaging studies or WBRT unsafe or poorly tolerated
- •Patient is receiving concurrent chemotherapy
- •Known allergic reaction to contrast or shellfish
- •Patients with brain metastases to be treated with radiosurgery
- •Patients with brain metastasis resulting from hematologic malignancies and small cell lung cancer
- •Implanted metal devices or foreign bodies that serve as a contraindication to MR imaging
- •Creatinine > 1.4 mg/dl and creatinine clearance < 20 mg/dl
- •Uncontrolled, clinically significant cardiac arrhythmias
- •Severe claustrophobia
- •Pregnant female
- •Any prior radiation therapy to the brain
- •KPS < 70
- •Patients with leptomeningeal disease
研究组 & 干预措施
Diagnostic (VB-DTI, MRI)
Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
干预措施: diffusion tensor imaging (Procedure)
Diagnostic (VB-DTI, MRI)
Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
干预措施: whole-brain radiation therapy (Radiation)
Diagnostic (VB-DTI, MRI)
Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
干预措施: stereotactic radiosurgery (Radiation)
Diagnostic (VB-DTI, MRI)
Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
干预措施: contrast-enhanced magnetic resonance imaging (Procedure)
Diagnostic (VB-DTI, MRI)
Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
干预措施: diffusion-weighted magnetic resonance imaging (Procedure)
结局指标
主要结局
Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion
时间窗: At 4 months
Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value \< 0.05.
Volumetric radiographic response for each lesion
时间窗: At 4 months
Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value \< 0.05. Statistical significance will be achieved with a p value \< 0.05.
Change in a lesion's overall mean ADC
时间窗: Baseline to 4 months
Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value \< 0.05. Statistical significance will be achieved with a p value \< 0.05.
Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion
时间窗: Up to 3 years
次要结局
未报告次要终点
研究者
Madhur Garg
Principal Investigator
Albert Einstein College of Medicine