Hepatocellular CancerFORCENCT02929082
Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer
A study testing IRM with a 5-minute- additional sequence to measure FRM in people with Hepatocellular Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- IRM with a 5-minute- additional sequence to measure FRM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Hepatocellular Cancer
- Being tested
- IRM with a 5-minute- additional sequence to measure FRM
- Keywords
- magnetic resonance force
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRM with a 5-minute- additional sequence to measure FRMRadiation
Also called FRM
IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: IRM with a 5-minute- additional sequence to measure FRM |
| 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. Receives: Radiation: IRM with a 5-minute- additional sequence to measure FRM |
| 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 Receives: Radiation: IRM with a 5-minute- additional sequence to measure FRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumoral environment invasion assessed by the presence of microvascular invasion of the tumor capsule after pathological examination of the surgical pieces
Measured: 12 months
Secondary outcomes (2)
therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver
Measured: 12 months
Interstitial force and traction force at the cell/tumor interface assessed by FRM
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start23 Jan 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Vilgrain, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929082
- Sponsor's protocol ID
- P150412
- Acronym
- FORCE
- Status last verified
- Jun 2022
- First submitted
- 14 Sep 2016
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT02929082
- Acronym / sponsor ID
- FORCE / P150412
- Conditions
- Hepatocellular Cancer
- Keywords
- magnetic resonance force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : volunteer patient | Experimental | Radiation: IRM with a 5-minute- additional sequence to measure FRMGroup 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 | Radiation: IRM with a 5-minute- additional sequence to measure FRMGroup 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 | Radiation: IRM with a 5-minute- additional sequence to measure FRMGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRM with a 5-minute- additional sequence to measure FRMAlso: FRMIRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3 | Radiation | Group 1 : volunteer patient, Group 2 : patient with resectable HCC, Group 3 : patient with HCC eligible for TACE |
Primary outcome
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
2 secondary outcomes
therapeutical results of TACE assessed by percentage of nodular necrosis in HCC after pathological examination of the explant liver
Time frame: 12 months
Interstitial force and traction force at the cell/tumor interface assessed by FRM
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Vilgrain principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRM with a 5-minute- additional sequence to measure FRM in people with Hepatocellular Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.