Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 21
- 主要终点
- Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)
研究概览
简要总结
The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).
详细描述
The advancements of systemic and local therapies for complex CRLM have led to the increased incidence of DLMs. It is hypothesized that DW-MRI imaging could distinguish between a metastasis not completely sterilized by conversion therapy and a sterilized scar (non-viable tumor). If this can be demonstrated, the use of DW-MRI could make a significant impact on the surgical decision making process by providing surgeons a more reliable guide to decide whether to leave behind or to resect/ablate a site of DLM. Most importantly, this surgical choice can also have a significant impact on patient outcomes as it may impact the risk of local recurrence and the need for re-operation.The possibility of improving surgical management of complex CRLM is foreseen if the benefit of observing or resecting small residual metastases and DLMs is clarified through a multi-center and international prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Contraindications to any contrast agents for CT and MRI or MRI procedure
- •Significant comorbidity that will preclude either conversion therapy or surgery
结局指标
主要结局
Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)
时间窗: 2 years after surgery
次要结局
- Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy(2 years after the surgery)
- NPV of diagnostic imaging among the group of resected confirmed DLMs(2 years after the surgery)
- NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review(2 years after the surgery)
- Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS(2 years after initial surgery)
- NPV of diagnostic imaging in the group of confirmed DLMs that were left in place(2 years after ther surgery)
- Long term outcomes of patients who underwent surgery in terms of: - recurrence rates for 2 years after surgery - progression free survival for 2 years after surgery - overall survival for 2 years after surgery(2 years after initial surgery)