{
    "info": {
        "nct_id": "NCT05574920",
        "official_title": "Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study",
        "inclusion_criteria": "* age 18-80 years old;\n* newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;\n* BC clinical stagecT1-3 cN0-3 M0;\n* no prior treatment for BC.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* pregnancy;\n* breastfeeding;\n* patients who were unwilling to undergo PET/CT scans.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* age 18-80 years old;",
                "criterions": [
                    {
                        "exact_snippets": "age 18-80 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "age 18-80 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;",
                "criterions": [
                    {
                        "exact_snippets": "newly diagnosed BC confirmed by biopsy",
                        "criterion": "breast cancer diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    },
                    {
                        "exact_snippets": "BI-RADS category 4C or 5 lesions by US or MG",
                        "criterion": "BI-RADS category",
                        "requirement": {
                            "requirement_type": "category",
                            "expected_value": [
                                "4C",
                                "5"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "BI-RADS category 4C or 5 lesions by US",
                        "criterion": "imaging method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "ultrasound"
                        }
                    },
                    {
                        "exact_snippets": "BI-RADS category 4C or 5 lesions by ... MG",
                        "criterion": "imaging method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "mammography"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "newly diagnosed BC confirmed by biopsy",
                                "criterion": "breast cancer diagnosis",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": "biopsy"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "BI-RADS category 4C or 5 lesions by US or MG",
                                "criterion": "BI-RADS category",
                                "requirement": {
                                    "requirement_type": "category",
                                    "expected_value": [
                                        "4C",
                                        "5"
                                    ]
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "BI-RADS category 4C or 5 lesions by US",
                                        "criterion": "imaging method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "ultrasound"
                                        }
                                    },
                                    {
                                        "exact_snippets": "BI-RADS category 4C or 5 lesions by ... MG",
                                        "criterion": "imaging method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "mammography"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* no prior treatment for BC.",
                "criterions": [
                    {
                        "exact_snippets": "no prior treatment for BC",
                        "criterion": "prior treatment for BC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no prior treatment for BC",
                        "criterion": "prior treatment for BC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* BC clinical stagecT1-3 cN0-3 M0;",
                "criterions": [
                    {
                        "exact_snippets": "BC clinical stage cT1-3",
                        "criterion": "breast cancer clinical stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "cN0-3",
                        "criterion": "regional lymph node involvement",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "M0",
                        "criterion": "distant metastasis",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "BC clinical stage cT1-3",
                        "criterion": "breast cancer clinical stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "cN0-3",
                        "criterion": "regional lymph node involvement",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "M0",
                        "criterion": "distant metastasis",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* pregnancy;",
                "criterions": [
                    {
                        "exact_snippets": "pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* breastfeeding;",
                "criterions": [
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* patients who were unwilling to undergo PET/CT scans.",
                "criterions": [
                    {
                        "exact_snippets": "unwilling to undergo PET/CT scans",
                        "criterion": "willingness to undergo PET/CT scans",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "unwilling to undergo PET/CT scans",
                    "criterion": "willingness to undergo PET/CT scans",
                    "requirement": {
                        "requirement_type": "willingness",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}