Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces
研究概览
简要总结
FORCE project aims to measure actives forces of malignant tumor by magnetic resonance force (FRM). Two main forces are considered as key indicators of therapeutic response and metastatic potential: interstitial force and traction force at the interface cell/tumor. Biomarkers of these forces will be developped using direct images of magnetic resonance force (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their capacity to predict tumoral environment invasion, notably micro-vascular invasion, and therapeutical results in Hepatocellular Cancer (HCC).
Principal criteria will be
- micro-vascular invasion assessed by pathological examination of surgical pieces (gold standard).
- interstitial force and traction force at the cell/tumor interface assessed by FRM.
Population of patients will be divided in three groups. A first group will be constituted of 20 volunteer patients coming for abdominal MRI with no known hepatic disease, in order to determine the feasibility of FRM. A second group will be constituted of 60 patients with resectable HCC eligible for surgery. This group will enable to evaluate the tumoral environment invasion. Third group will be constituted of 50 patients with HCC eligible for transplant with transcatheter arterial chemoembolization (TACE) treatment as pending treatment before transplant. This groups will enable to evaluate the efficiency of TACE through the necrosis percentage in treated HCC.
Inclusion of patients will occur during 24 months for a total study duration of 36 months.
All patients will have MRI as usual care. FRM is performed during MRI with the use of a specific medical device and therefore corresponds to an additional procedure of the research.
Moreover, patients in group 2 and 3 will be asked to participate to an ancillary study consisting in circulating tumoral cells (CTC) measurement. If they accept, a blood sample will be collected just before the MRI in order to evaluate the correlation between CTC and micro-vascular invasion.
详细描述
FORCE project aims to measure actives forces of malignant tumor by FRM. Two main forces are considered as key indicators of therapeutic response and metastatic potential: interstitial force and traction force at the cell/tumor interface. Biomarkers of these forces will be developped using direct images of magnetic resonance force (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their capacity to predict tumoral environment invasion, notably micro-vascular invasion, and therapeutical results in Hepatocellular Cancer (HCC).
Principal criteria will be
- micro-vascular invasion assessed by pathological examination of surgical pieces (gold standard).
- interstitial force and traction force at the cell/tumor interface assessed by FRM.
Secondary criteria will be :
- Percentage of nodular necrosis in HCC as a marker of a therapeutic response assessed by pathological examination of explant liver (gold standard).
- interstitial force and traction force at the cell/tumor interface assessed by FRM.
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
- 是
入选标准
- •Group 1 : adults (≥ 18 y.o.) with life expectancy upper than 3 months; planified pancreatic or biliary MRI; signed informed consent form; affiliated to social security or equivalent.
- •Group 2 : adults (≥ 18 y.o.) with life expectancy upper than 3 months; with HCC diagnosed by histological or cytological means or following EORTC/EASL criteria; eligible for HCC resection; treatment-naive patients for studied HCC lesion; signed informed consent form; affiliated to social security or equivalent.
- •Group 3 : adults (≥ 18 y.o.) with life expectancy upper than 3 months; with HCC diagnosed by histological or cytological means or following EORTC/EASL criteria; eligible for hepatic transplant; eligible TACE treatment as pending treatment before transplant; treatment-naive patients for studied HCC lesion for treatments other than TACE; signed informed consent form; affiliated to social security or equivalent.
排除标准
- •Group 1 : known chronic hepatic disease; contraindication for MRI as defined by the French Radiology Society.
- •Group 2 : patients previously treated for studied HCC lesion; contraindication for MRI as defined by the French Radiology Society.
- •Group 3 :patients previously treated for studied HCC lesion (except if TACE); contraindication for MRI as defined by the French Radiology Society.
结局指标
主要结局
Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces
时间窗: 12 months
次要结局
- therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver(12 months)
- Interstitial force and traction force at the cell/tumor interface assessed by FRM(12 months)