Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Absolute change in the true diffusion coefficient (D)
研究概览
简要总结
This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.
SECONDARY OBJECTIVES:
I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.
II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)/leucovorin (FOLFOX), irinotecan with 5-FU/leucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent
- •Patients with at least 1 colorectal liver metastasis measuring at least 1 cm
- •Patients with anticipated follow-up before and after surgery at MD Anderson
排除标准
- •Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver
- •Patients allergic to gadolinium
- •Patients with pacemakers
- •Greater than 400 pounds in weight
研究组 & 干预措施
Diagnostic (IVIM DWI)
Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.
干预措施: Diffusion Weighted Imaging (Procedure)
结局指标
主要结局
Absolute change in the true diffusion coefficient (D)
时间窗: Up to 3 months or 5 months (each cycle is 28 days)
The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test.
次要结局
- Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging(Up to 3 months or 5 months (each cycle is 28 days))