{
    "info": {
        "nct_id": "NCT04310891",
        "official_title": "Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy",
        "inclusion_criteria": "1. Aged 18 or older.\n2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study.\n3. Patients undergoing external beam radiotherapy.\n4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).\n5. Diagnostic CT prior to insertion of fiducial markers.\n6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).\n7. ECOG performance status 0-2.\n8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.\n9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.\n10. The distance between the tumour centroid and the top end of the diaphragm is <=8 cm.\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Patient has low respiratory performance as evaluated by the physicians.\n2. Previous high-dose thoracic radiotherapy.\n3. Less than one fiducial marker implanted in the lung.\n4. Fiducial markers are too far from the tumour centroid (>9 cm).\n5. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).\n6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy.\n7. Women who are pregnant or lactating.\n8. Unwilling or unable to give informed consent.\n9. Unwilling or unable to complete quality of life questionnaires.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Aged 18 or older.",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study.",
            "criterions": [
                {
                    "exact_snippets": "provided written Informed Consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to comply with the study",
                    "criterion": "willingness to comply",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients undergoing external beam radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing external beam radiotherapy",
                    "criterion": "external beam radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven Stage I NSCLC",
                    "criterion": "Stage I NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "oligometastatic lung metastases (3 or less)",
                    "criterion": "oligometastatic lung metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Diagnostic CT prior to insertion of fiducial markers.",
            "criterions": [
                {
                    "exact_snippets": "Diagnostic CT prior to insertion of fiducial markers.",
                    "criterion": "diagnostic CT",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to insertion of fiducial markers"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able to have fiducial markers placed in the lung",
                    "criterion": "fiducial marker placement in the lung",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if on anticoagulants, must be cleared by LMO or cardiologist",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": [
                                "LMO",
                                "cardiologist"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG performance status 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.",
            "criterions": [
                {
                    "exact_snippets": "A maximum of three metastases to the lung",
                    "criterion": "lung metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "metastases"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "from any non-haematological malignancy",
                    "criterion": "non-haematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.",
            "criterions": [
                {
                    "exact_snippets": "1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm",
                    "criterion": "tumour diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. The distance between the tumour centroid and the top end of the diaphragm is <=8 cm.",
            "criterions": [
                {
                    "exact_snippets": "distance between the tumour centroid and the top end of the diaphragm is <=8 cm",
                    "criterion": "distance between tumour centroid and diaphragm",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patient has low respiratory performance as evaluated by the physicians.",
            "criterions": [
                {
                    "exact_snippets": "low respiratory performance",
                    "criterion": "respiratory performance",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous high-dose thoracic radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Previous high-dose thoracic radiotherapy",
                    "criterion": "thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Less than one fiducial marker implanted in the lung.",
            "criterions": [
                {
                    "exact_snippets": "Less than one fiducial marker implanted in the lung.",
                    "criterion": "fiducial marker in the lung",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Fiducial markers are too far from the tumour centroid (>9 cm).",
            "criterions": [
                {
                    "exact_snippets": "Fiducial markers are too far from the tumour centroid (>9 cm).",
                    "criterion": "distance of fiducial markers from tumour centroid",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).",
            "criterions": [
                {
                    "exact_snippets": "Cytotoxic chemotherapy within 3 weeks of commencement of treatment",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently with treatment",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hormonal manipulation agents are allowable",
                    "criterion": "hormonal manipulation agents",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment",
                    "criterion": "use of targeted agents",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of commencement of treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Targeted agents (such as sunitinib, bevacizumab and tarceva) ... concurrently with treatment",
                    "criterion": "use of targeted agents",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "concurrently with treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Targeted agents (such as sunitinib, bevacizumab and tarceva) ... 7 days after radiotherapy",
                    "criterion": "use of targeted agents",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "7 days after radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women who are pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are ... lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Unwilling or unable to give informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Unwilling ... to give informed consent.",
                    "criterion": "willingness to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to give informed consent.",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Unwilling or unable to complete quality of life questionnaires.",
            "criterions": [
                {
                    "exact_snippets": "Unwilling ... to complete quality of life questionnaires.",
                    "criterion": "willingness to complete quality of life questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to complete quality of life questionnaires.",
                    "criterion": "ability to complete quality of life questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}