{
    "info": {
        "nct_id": "NCT06715020",
        "official_title": "Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging",
        "inclusion_criteria": "1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);\n2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;\n3. Patients with confirmed or suspected breast cancer;\n4. Expected survival ≥12 weeks;\n5. Good follow-up compliance;\n6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;\n7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Unable to obtain informed consent;\n5. Suffering from claustrophobia or other mental illness;\n6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;\n7. Other conditions deemed unsuitable for participation in the trial by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);",
            "criterions": [
                {
                    "exact_snippets": "Age 18-75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG score 0 or 1 points",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;",
            "criterions": [
                {
                    "exact_snippets": "Blood routine: WBC ≥ 4.0×109 L",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4.0,
                                "unit": "×10^9 L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood routine: ... neutrophil ≥1.5×109 /L",
                    "criterion": "neutrophil",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood routine: ... PLT ≥ 100×109/L",
                    "criterion": "PLT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood routine: ... Hb≥ 90 g/L",
                    "criterion": "Hb",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT or APTT ≤ 1.5 ULN",
                    "criterion": "PT or APTT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal)",
                    "criterion": "T-Bil",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULT"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver and kidney function: ... ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis)",
                    "criterion": "ALT and AST",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver and kidney function: ... ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis)",
                    "criterion": "ALP",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver and kidney function: ... BUN ≤ 1.5×ULT",
                    "criterion": "BUN",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULT"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver and kidney function: ... SCr ≤ 1.5×ULT",
                    "criterion": "SCr",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULT"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with confirmed or suspected breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "confirmed or suspected breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "confirmed",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Expected survival ≥12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival ≥12 weeks",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Good follow-up compliance;",
            "criterions": [
                {
                    "exact_snippets": "Good follow-up compliance",
                    "criterion": "follow-up compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing age (15 to 49 years old)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 15,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 49,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing age ... must undergo a pregnancy test within 7 days before the start of the test and the result is negative",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before the start of the test"
                        },
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile men and women must consent to the use of effective contraception",
                    "criterion": "use of effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 3 months of the examination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Subject patients can fully understand",
                    "criterion": "understanding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily participate",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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 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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Severe abnormal liver and kidney function;",
            "criterions": [
                {
                    "exact_snippets": "Severe abnormal liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe abnormal ... kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnant, pregnant and lactating women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Can not lie flat for half an hour;",
            "criterions": [
                {
                    "exact_snippets": "Can not lie flat for half an hour",
                    "criterion": "ability to lie flat",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "minutes"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Unable to obtain informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Unable to obtain informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtainability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Suffering from claustrophobia or other mental illness;",
            "criterions": [
                {
                    "exact_snippets": "Suffering from claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;",
            "criterions": [
                {
                    "exact_snippets": "allergic to the investigational drug",
                    "criterion": "allergy to investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... its excipients in the investigational therapy",
                    "criterion": "allergy to excipients in investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Other conditions deemed unsuitable for participation in the trial by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Other conditions deemed unsuitable for participation in the trial by the investigator.",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "deemed unsuitable by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}