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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
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.
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
Secondary criteria will be :
Population of patients will be divided in three groups (see below). Inclusion of patients will occur during 24 months for a total study duration of 36 months.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : volunteer patient | Experimental | Group 1 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 5-minute- additional sequence to measure FRM will be done for the volunteers. |
|
| Group 2 : patient with resectable HCC | Experimental | Group 2 will be constituted of 60 patients with resectable HCC eligible for surgery. This group will enable to evaluate the gold standard. A 5-minute- additional sequence to measure FRM will be done while MRI sequence. |
|
| Group 3 : patient with HCC eligible for TACE | Experimental | Group 3 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. A 5-minute- additional sequence to measure FRM will be done while MRI sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRM with a 5-minute- additional sequence to measure FRM | Radiation | IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Vilgrain | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valérie Vilgrain | Clichy | 92110 | France |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
| D008107 |
| Liver Diseases |