{
    "info": {
        "nct_id": "NCT02003339",
        "official_title": "Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma",
        "inclusion_criteria": "* Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting.\n* Isolated target on initial imagery (invasive hepatocellular carcinoma excluded)\n* WHO (World Health organization) Performance status: 0, 1 or 2\n* If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter\n* Creatinine clearance more or equal to 30 mL/min\n* Patient informed and consent signature obtained\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Invasive hepatocellular carcinoma without any isolated tumor\n* Disease needing 2 injections of Therasphere\n* Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis\n* Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization\n* No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib\n* Associated disease which could prevent patient from receiving treatment\n* RMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)\n* Patient already participating in an other therapeutic trial with an experimental drug\n* Pregnant or childbearing potential women or breastfeeding women\n* minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons\n* Unable to sign an informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma"
                    ],
                    "criterion": "Hepatocellular Carcinoma",
                    "requirement_type": "stage",
                    "expected_value": [
                        "early",
                        "intermediate",
                        "advanced"
                    ]
                },
                {
                    "exact_snippets": [
                        "non metastatic Hepatocellular Carcinoma"
                    ],
                    "criterion": "Hepatocellular Carcinoma",
                    "requirement_type": "metastasis",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Indication for radioembolization validated after pluridisciplinary committee meeting"
                    ],
                    "criterion": "indication for radioembolization",
                    "requirement_type": "validation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Isolated target on initial imagery (invasive hepatocellular carcinoma excluded)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Isolated target on initial imagery"
                    ],
                    "criterion": "isolated target",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "invasive hepatocellular carcinoma excluded"
                    ],
                    "criterion": "invasive hepatocellular carcinoma",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* WHO (World Health organization) Performance status: 0, 1 or 2",
            "criterions": [
                {
                    "exact_snippets": [
                        "WHO (World Health organization) Performance status"
                    ],
                    "criterion": "WHO Performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1",
                        "2"
                    ]
                }
            ]
        },
        {
            "line": "* If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter",
            "criterions": [
                {
                    "exact_snippets": [
                        "cirrhosis"
                    ],
                    "criterion": "cirrhosis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Child A score"
                    ],
                    "criterion": "Child-Pugh score",
                    "requirement_type": "classification",
                    "expected_value": "Child A"
                },
                {
                    "exact_snippets": [
                        "total bilirubin",
                        "less than 30 micromoles per liter"
                    ],
                    "criterion": "total bilirubin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Creatinine clearance more or equal to 30 mL/min",
            "criterions": [
                {
                    "exact_snippets": [
                        "Creatinine clearance",
                        "more or equal to 30 mL/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patient informed and consent signature obtained",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient informed"
                    ],
                    "criterion": "patient",
                    "requirement_type": "informed",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "consent signature obtained"
                    ],
                    "criterion": "consent signature",
                    "requirement_type": "obtained",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Invasive hepatocellular carcinoma without any isolated tumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Invasive hepatocellular carcinoma"
                    ],
                    "criterion": "hepatocellular carcinoma",
                    "requirement_type": "invasiveness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "without any isolated tumor"
                    ],
                    "criterion": "isolated tumor",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Disease needing 2 injections of Therasphere",
            "criterions": [
                {
                    "exact_snippets": [
                        "Disease needing 2 injections of Therasphere"
                    ],
                    "criterion": "disease",
                    "requirement_type": "treatment requirement",
                    "expected_value": "2 injections of Therasphere"
                }
            ]
        },
        {
            "line": "* Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis",
            "criterions": [
                {
                    "exact_snippets": [
                        "Thrombosis extending into the porta"
                    ],
                    "criterion": "thrombosis",
                    "requirement_type": "location",
                    "expected_value": "extending into the porta"
                },
                {
                    "exact_snippets": [
                        "thrombosis of one of left or right branch authorized"
                    ],
                    "criterion": "thrombosis",
                    "requirement_type": "location",
                    "expected_value": "one of left or right branch"
                },
                {
                    "exact_snippets": [
                        "extra hepatic metastasis"
                    ],
                    "criterion": "metastasis",
                    "requirement_type": "location",
                    "expected_value": "extra hepatic"
                }
            ]
        },
        {
            "line": "* Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous treatment by chemoembolization"
                    ],
                    "criterion": "chemoembolization",
                    "requirement_type": "previous treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Previous treatment by",
                        "radiofrequency"
                    ],
                    "criterion": "radiofrequency",
                    "requirement_type": "previous treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "less than 3 months before radioembolization"
                    ],
                    "criterion": "time since last treatment",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib",
            "criterions": [
                {
                    "exact_snippets": [
                        "No antiangiogenic concomitant treatment"
                    ],
                    "criterion": "antiangiogenic treatment",
                    "requirement_type": "concomitant",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "15 days before and 15 days after radioembolization"
                    ],
                    "criterion": "antiangiogenic treatment",
                    "requirement_type": "timing restriction",
                    "expected_value": "15 days before and 15 days after radioembolization"
                },
                {
                    "exact_snippets": [
                        "including Sorafenib"
                    ],
                    "criterion": "Sorafenib",
                    "requirement_type": "inclusion in antiangiogenic treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Associated disease which could prevent patient from receiving treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Associated disease which could prevent patient from receiving treatment"
                    ],
                    "criterion": "associated disease",
                    "requirement_type": "impact on treatment",
                    "expected_value": "could prevent treatment"
                }
            ]
        },
        {
            "line": "* RMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)",
            "criterions": [
                {
                    "exact_snippets": [
                        "RMI contre-indication",
                        "particle or metal prosthesis"
                    ],
                    "criterion": "RMI",
                    "requirement_type": "contraindication",
                    "expected_value": "particle or metal prosthesis"
                },
                {
                    "exact_snippets": [
                        "RMI contre-indication",
                        "pacemaker"
                    ],
                    "criterion": "RMI",
                    "requirement_type": "contraindication",
                    "expected_value": "pacemaker"
                },
                {
                    "exact_snippets": [
                        "RMI contre-indication",
                        "claustrophobia"
                    ],
                    "criterion": "RMI",
                    "requirement_type": "contraindication",
                    "expected_value": "claustrophobia"
                },
                {
                    "exact_snippets": [
                        "contrast product contre-indication",
                        "allergy"
                    ],
                    "criterion": "contrast product",
                    "requirement_type": "contraindication",
                    "expected_value": "allergy"
                }
            ]
        },
        {
            "line": "* Patient already participating in an other therapeutic trial with an experimental drug",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient already participating in an other therapeutic trial"
                    ],
                    "criterion": "participation in another therapeutic trial",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "experimental drug"
                    ],
                    "criterion": "experimental drug",
                    "requirement_type": "use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnant or childbearing potential women or breastfeeding women",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons",
            "criterions": [
                {
                    "exact_snippets": [
                        "minors"
                    ],
                    "criterion": "age",
                    "requirement_type": "category",
                    "expected_value": "minor"
                },
                {
                    "exact_snippets": [
                        "persons deprived of liberty"
                    ],
                    "criterion": "legal status",
                    "requirement_type": "category",
                    "expected_value": "deprived of liberty"
                },
                {
                    "exact_snippets": [
                        "protected adults",
                        "maintenance of justice, guardianship or supervision"
                    ],
                    "criterion": "legal status",
                    "requirement_type": "category",
                    "expected_value": "protected adult"
                },
                {
                    "exact_snippets": [
                        "Unable to comply with trial medical follow-up",
                        "geographical, social or psychological reasons"
                    ],
                    "criterion": "ability to comply with trial follow-up",
                    "requirement_type": "compliance",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Unable to sign an informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unable to sign an informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "ability to sign",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}