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Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer (FORCE)

Primary Purpose

Hepatocellular Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IRM with a 5-minute- additional sequence to measure FRM
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Cancer focused on measuring magnetic resonance force

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Valérie Vilgrain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 : volunteer patient

Group 2 : patient with resectable HCC

Group 3 : patient with HCC eligible for TACE

Arm Description

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 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 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

Outcomes

Primary Outcome Measures

Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces

Secondary Outcome Measures

therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver
Interstitial force and traction force at the cell/tumor interface assessed by FRM

Full Information

First Posted
September 14, 2016
Last Updated
June 20, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02929082
Brief Title
Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer
Acronym
FORCE
Official Title
Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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. 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. Group 2 will be constituted of 60 patients with resectable HCC eligible for surgery. This group will enable to evaluate the tumoral environment invasion. Patients of this group will be selected during multidisciplinary medical meetings. If they accept to participate to the ancillary study, a blood sample will be collected (2 tubes of 6 mL and 10 mL respectively) just before the MRI, an exam always performed before hepatic resection with a 5-minute- additional sequence to measure FRM. As soon as the surgery is performed, surgery pieces will be analysed by anatomopathology laboratory in order to assess, notably, presence of mirco-vascular invasion. 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. Patients of this group will be selected during multidisciplinary medical meetings. If TACE was already performed at inclusion and if patient accepts to participate to the ancillary study, a blood sample will be collected (2 tubes of 6 mL and 10 mL respectively) just before the MRI, an exam always performed before hepatic transplant with a 5-minute- additional sequence to measure FRM. As soon as the transplant is performed, surgery pieces (whole patient liver) will be analysed by anatomopathology laboratory in order to assess, notably, presence of necrosis on HCC nodules previously treated by TACE. If TACE was not performed at inclusion, TACE will be planified as usually. Data from TACE will be collected in the case report form (CRF). After TACE, same exams will be performed as described above. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
Keywords
magnetic resonance force

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : volunteer patient
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 : patient with resectable HCC
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3 : patient with HCC eligible for TACE
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
IRM with a 5-minute- additional sequence to measure FRM
Other Intervention Name(s)
FRM
Intervention Description
IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
Primary Outcome Measure Information:
Title
Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces
Time Frame
12 months
Secondary Outcome Measure Information:
Title
therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver
Time Frame
12 months
Title
Interstitial force and traction force at the cell/tumor interface assessed by FRM
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Vilgrain
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valérie Vilgrain
City
Clichy
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer

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