{
    "info": {
        "nct_id": "NCT05609448",
        "official_title": "Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study",
        "inclusion_criteria": "1. Diagnosis of hepatocellular carcinoma BCLC stage B or C\n2. At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT\n3. Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO)\n4. Patient has a life expectancy of 12 weeks or longer\n5. Patient has a WHO performance score of 0-2\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)\n2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment\n3. Serum bilirubin > 2.0 x the upper limit of normal\n4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal\n5. Leukocytes <4.0 * 109/L or platelet count <60 * 109/L\n6. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.\n7. Pregnancy or breast feeding\n8. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum\n9. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)\n10. Portal vein thrombosis of the main branch (more distal branches are allowed)\n11. Untreated, active hepatitis\n12. Body weight > 150 kg (because of maximum table load)\n13. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)\n14. Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT.\n15. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.\n16. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Diagnosis of hepatocellular carcinoma BCLC stage B or C",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of hepatocellular carcinoma",
                    "criterion": "hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BCLC stage B or C",
                    "criterion": "BCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT",
            "criterions": [
                {
                    "exact_snippets": "At least one lesion of 10 mm or more in the longest diameter",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on contrast-enhanced MRI/CT",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "contrast-enhanced MRI",
                                "CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO)",
            "criterions": [
                {
                    "exact_snippets": "eligible for TARE as determined by the tumour board",
                    "criterion": "eligibility for TARE",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "tumour board"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has a life expectancy of 12 weeks or longer",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of 12 weeks or longer",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient has a WHO performance score of 0-2",
            "criterions": [
                {
                    "exact_snippets": "WHO performance score of 0-2",
                    "criterion": "WHO performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)",
            "criterions": [
                {
                    "exact_snippets": "Extrahepatic disease that cannot be targeted during the TARE session",
                    "criterion": "extrahepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "targetability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "enlarged lymph nodes in the liver hilus are allowed",
                    "criterion": "enlarged lymph nodes in the liver hilus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy ... within 4 weeks before treatment",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy ... within 4 weeks before treatment",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "major surgery within 4 weeks before treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Serum bilirubin > 2.0 x the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin > 2.0 x the upper limit of normal",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "x the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "ALAT ... > 5x the upper limit of normal",
                    "criterion": "ALAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ASAT ... > 5x the upper limit of normal",
                    "criterion": "ASAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase (AF) ... > 5x the upper limit of normal",
                    "criterion": "alkaline phosphatase (AF)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Leukocytes <4.0 * 109/L or platelet count <60 * 109/L",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes <4.0 * 109/L",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 4.0,
                                "unit": "* 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count <60 * 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "* 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.",
            "criterions": [
                {
                    "exact_snippets": "Significant heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "increases the risk of ventricular arrhythmia",
                    "criterion": "risk of ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnancy or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum",
            "criterions": [
                {
                    "exact_snippets": "Disease with increased chance of liver toxicity",
                    "criterion": "disease with increased chance of liver toxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "primary biliary cirrhosis",
                    "criterion": "primary biliary cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "xeroderma pigmentosum",
                    "criterion": "xeroderma pigmentosum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)",
            "criterions": [
                {
                    "exact_snippets": "ineligible to undergo MR-imaging",
                    "criterion": "MR-imaging eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metal implants",
                    "criterion": "metal implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Portal vein thrombosis of the main branch (more distal branches are allowed)",
            "criterions": [
                {
                    "exact_snippets": "Portal vein thrombosis of the main branch",
                    "criterion": "portal vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "main branch"
                        }
                    ]
                },
                {
                    "exact_snippets": "more distal branches are allowed",
                    "criterion": "portal vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "more distal branches"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Untreated, active hepatitis",
            "criterions": [
                {
                    "exact_snippets": "Untreated, active hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Body weight > 150 kg (because of maximum table load)",
            "criterions": [
                {
                    "exact_snippets": "Body weight > 150 kg",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)",
            "criterions": [
                {
                    "exact_snippets": "Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)",
                    "criterion": "allergy to i.v. contrast",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "specific agents",
                            "expected_value": [
                                "Iomeron",
                                "Dotarem",
                                "Primovist"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT.",
            "criterions": [
                {
                    "exact_snippets": "Lung shunt > 30 Gy",
                    "criterion": "lung shunt",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.",
            "criterions": [
                {
                    "exact_snippets": "Uncorrectable extrahepatic deposition of scout dose activity",
                    "criterion": "extrahepatic deposition of scout dose activity",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted",
                    "criterion": "activity in specific locations",
                    "requirements": [
                        {
                            "requirement_type": "locations",
                            "expected_value": [
                                "falciform ligament",
                                "portal lymph nodes",
                                "gallbladder"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.",
            "criterions": [
                {
                    "exact_snippets": "Unstable final catheter position",
                    "criterion": "catheter position",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic artery anatomy",
                    "criterion": "hepatic artery anatomy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}