{
    "info": {
        "nct_id": "NCT01482182",
        "official_title": "Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET",
        "inclusion_criteria": "* Histologically proven NSCLC\n* Newly diagnosed Stage stage IV\n* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy\n* At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST\n* Performance status of 0 to 2 on the ECOG scale\n* Age 18 years or older\n* Able to tolerable PET/CT and MRI imaging required by protocol\n* Able to give study-specific informed consent\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Pure bronchioloalveolar cell carcinoma histology\n* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study\n* Poorly controlled diabetes\n* Prior malignancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed Stage stage IV",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed Stage stage IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy",
            "criterions": [
                {
                    "exact_snippets": "Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy",
                    "criterion": "chemotherapy with EGFR TKI",
                    "requirements": [
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": "first line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
                    "criterion": "intrathoracic lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status of 0 to 2 on the ECOG scale",
            "criterions": [
                {
                    "exact_snippets": "Performance status of 0 to 2 on the ECOG scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to tolerable PET/CT and MRI imaging required by protocol",
            "criterions": [
                {
                    "exact_snippets": "Able to tolerable PET/CT and MRI imaging",
                    "criterion": "tolerance to imaging",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to give study-specific informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to give study-specific informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pure bronchioloalveolar cell carcinoma histology",
            "criterions": [
                {
                    "exact_snippets": "Pure bronchioloalveolar cell carcinoma histology",
                    "criterion": "bronchioloalveolar cell carcinoma histology",
                    "requirements": [
                        {
                            "requirement_type": "purity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study",
            "criterions": [
                {
                    "exact_snippets": "Thoracic radiotherapy ... within three months prior to inclusion in the study",
                    "criterion": "thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lung surgery ... within three months prior to inclusion in the study",
                    "criterion": "lung surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy within three months prior to inclusion in the study",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled diabetes",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior malignancy",
            "criterions": [
                {
                    "exact_snippets": "Prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}