{
    "info": {
        "nct_id": "NCT00905801",
        "official_title": "CTP (Computed Tomography Perfusion) Imaging of Lung Cancer",
        "inclusion_criteria": "* Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging with CT of the chest with intravenous contrast as standard of care. Other imaging tests will be performed as clinically indicated.\n* Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.\n* Histologically or cytologically proven NSCLC.\n* At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. A scan within 3-6 months prior to registration can be used as the baseline scan.\n* Age 18 years or older and ability to provide informed consent.\n* Subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding\n* Subjects must have normal renal function to participate. Standard laboratory testing to evaluate renal function will be performed prior to administering IV contrast and will be available as standard of care. Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum creatinine concentration.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;\n* Established allergy to iodine containing contrast media",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging with CT of the chest with intravenous contrast as standard of care. Other imaging tests will be performed as clinically indicated.",
            "criterions": [
                {
                    "exact_snippets": "any stage non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging with CT of the chest with intravenous contrast",
                    "criterion": "CT imaging of the chest with intravenous contrast",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents)",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "receiving",
                                "planning to receive",
                                "have received"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with or without radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients should not be receiving adjuvant or postoperative treatment",
                    "criterion": "adjuvant or postoperative treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "neoadjuvant treatment is allowed",
                    "criterion": "neoadjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically proven NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. A scan within 3-6 months prior to registration can be used as the baseline scan.",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "this lesion should be either proven to be malignant by biopsy",
                    "criterion": "lesion malignancy",
                    "requirements": [
                        {
                            "requirement_type": "proof method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "this lesion should be ... considered malignant based on its evolution on previous imaging studies",
                    "criterion": "lesion malignancy",
                    "requirements": [
                        {
                            "requirement_type": "proof method",
                            "expected_value": "evolution on previous imaging studies"
                        }
                    ]
                },
                {
                    "exact_snippets": "A scan within 3-6 months prior to registration can be used as the baseline scan",
                    "criterion": "baseline scan timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older and ability to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Subjects must use medically appropriate contraception if sexually active",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "sexually active"
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "medically appropriate"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential must not be pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential must not be ... breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have normal renal function to participate. Standard laboratory testing to evaluate renal function will be performed prior to administering IV contrast and will be available as standard of care. Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum creatinine concentration.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must have normal renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min/1.73 m2 BSA"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;",
            "criterions": [
                {
                    "exact_snippets": "Subjects of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling and/or unable to use medically appropriate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Established allergy to iodine containing contrast media",
            "criterions": [
                {
                    "exact_snippets": "Established allergy to iodine containing contrast media",
                    "criterion": "allergy to iodine containing contrast media",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}