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

NCT02929082 | Completed

• 1 other identifier: P150412
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

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

Conditions

Hepatocellular Cancer

Keywords

magnetic resonance force

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (2)

• 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

Study Arms (3)

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.

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.

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

Radiation: IRM with a 5-minute- additional sequence to measure FRM

Interventions

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

Also known as: FRM

Group 1 : volunteer patient; Group 2 : patient with resectable HCC; Group 3 : patient with HCC eligible for TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Valérie Vilgrain

Clichy, 92110, France

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Valerie Vilgrain

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 10, 2016
• Study Start: January 23, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

FR (1)