Assessment of Diffusion-weighted Magnetic Resonance (MR) Imaging to Predict Chemotherapy Outcome in Liver Metastases and Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Apparent Diffusion Coefficient (ADC) value changes of the lesion during chemotherapy.
研究概览
简要总结
One of the most recent and interesting field of diagnostic imaging is diffusion-weighted MR imaging (DW-MRI). Various studies evaluated the application of DW-MRI to diffuse liver disease and focal liver lesions providing controversial results, probably due to the difficult reproducibility of the apparent diffusion coefficient (ADC) measurements. It is conceivable that a wide inter/intra-individual variability actually exists in the apparent diffusion coefficient (ADC)-values, and that each apparent diffusion coefficient (ADC)-value presents an higher reliability in measuring the temporal changes of water diffusion within the same individual (longitudinal-evaluation), than in characterizing tissues between different patients (transverse-evaluation). For these reasons, some previous studies assessed the application of DW-MRI in predicting the chemotherapy (CHT) outcome in liver metastases. The rationale of these studies was the overt biochemical changes shown by the neoplastic cells after CHT and the sensitivity of DW-MRI in the identification of such changes. The same authors noticed that the metastatic lesions with the lowest ADC-values present also the best outcome after CHT. Moreover, these studies suggest that it could be possible to assess if each single patient will respond (R) or not (NR) to the CHT through liver DW-MRI performed from 3 days to 3 weeks after the beginning of CHT.
详细描述
In R patients an increase of the mean diameter of the neoplastic cells should be present from the first week of CHT with a consequent reduction of the ADC-value. Then, the ADC-value should increase after 2-3 weeks due to the reduction of the cellular volume and to the increase of the membrane permeability. In NR patients, these biochemical changes should not be present with a consequent constant ADC-value before/after CHT. Our multicentre study will allow the recruitment of a higher number of patients vs. previous studies. Moreover, presently the outcome of CHT in liver metastases is evaluated only after 2-3 cycles of CHT according to the RECIST (Response-Evaluation-Criteria-In-Solid-Tumors) and then merely on a dimensional basis. Anyway, frequently liver metastases in R patients, can not show any significant dimensional change, while they present several biochemical/metabolic changes, not included in the RECIST, but probably detectable by DW-MRI.
The principal objective of the study is the early assessment of CHT outcome in liver metastases and advanced hepatocellular carcinoma (HCC). Patients with liver metastasis will be stratified as R and NR on the basis of the contrast-enhanced CT examination performed 20 days after the beginning of the second cycle of CHT; patients with HCC undergoing therapy with Sorafenib will be stratified as R and NR on the basis of the contrast-enhanced CT examination performed 90 days after the beginning of the therapy. The ADC-values obtained before and after the first CHT cycle will be compared between each patient category to assess the grade of agreement between the dimensional and functional parameters. Moreover, the investigators' aim is to assess whether those liver metastases or HCCs presenting a lower ADC-value before CHT are actually more responsive to CHT in comparison to liver metastases and HCCs presenting a higher ADC-value.
Secondary objectives: to propose some additional functional criteria to the RECIST 1.1 and mRECIST (for HCC) criteria based on water diffusion and biochemical changes of the neoplastic cells. As a further objective it is possible to hypothesize a different response to CHT of the different tumor histotypes detectable from the different ADC changes induced by CHT.
Patient population
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
- 未提供
结局指标
主要结局
Apparent Diffusion Coefficient (ADC) value changes of the lesion during chemotherapy.
时间窗: For metastasis: 2-4-8 weeks after CHT; for HCC: 30-60-90 days after CHT.
Linear regression analysis to assess the association between the ADC-value changes and the CHT outcome.
次要结局
未报告次要终点
研究者
Stefano Colagrande
Associate Professor of Radiology
University of Florence