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

June 20, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

  1. micro-vascular invasion assessed by pathological examination of surgical pieces (gold standard).
  2. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  1. micro-vascular invasion assessed by pathological examination of surgical pieces (gold standard).
  2. interstitial force and traction force at the cell/tumor interface assessed by FRM.

Secondary criteria will be :

  1. Percentage of nodular necrosis in HCC as a marker of a therapeutic response assessed by pathological examination of explant liver (gold standard).
  2. 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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92110
        • Valérie Vilgrain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 : volunteer patient
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.
Radiation: IRM with a 5-minute- additional sequence to measure FRM
IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
Other Names:
  • FRM
Experimental: Group 2 : patient with resectable HCC

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.
Radiation: IRM with a 5-minute- additional sequence to measure FRM
IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
Other Names:
  • FRM
Experimental: Group 3 : patient with HCC eligible for TACE

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
Radiation: IRM with a 5-minute- additional sequence to measure FRM
IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
Other Names:
  • FRM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver
Time Frame: 12 months
12 months
Interstitial force and traction force at the cell/tumor interface assessed by FRM
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Valerie Vilgrain, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2018

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P150412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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