{
    "info": {
        "nct_id": "NCT06020573",
        "official_title": "Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)",
        "inclusion_criteria": "1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)\n2. Solid tumor size ≥ 15 mm at screening, on sonography imaging\n3. Breast conserving surgery\n4. ≥ 18 years of age\n5. Ability to provide written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Neoadjuvant chemotherapy\n2. Bilateral breast conserving surgery\n3. Invasive lobular carcinoma, DCIS, LCIS\n4. Suspicion of extensive DCIS component of NST tumor\n5. Diagnosis of recurrent breast cancer\n6. Previous radiotherapy\n7. Patient is pregnant or lactating\n8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator\n9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)",
            "criterions": [
                {
                    "exact_snippets": "Female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary invasive breast cancer",
                    "criterion": "primary invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NST or NST with DCIS component",
                    "criterion": "breast cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": [
                                "NST",
                                "NST with DCIS component"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrine pretreatment according to standard of care therapy at the study site",
                    "criterion": "endocrine pretreatment",
                    "requirements": [
                        {
                            "requirement_type": "standard of care",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Solid tumor size ≥ 15 mm at screening, on sonography imaging",
            "criterions": [
                {
                    "exact_snippets": "Solid tumor size ≥ 15 mm",
                    "criterion": "solid tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on sonography imaging",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sonography"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Breast conserving surgery",
            "criterions": [
                {
                    "exact_snippets": "Breast conserving surgery",
                    "criterion": "breast conserving surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Ability to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written 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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Neoadjuvant chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Bilateral breast conserving surgery",
            "criterions": [
                {
                    "exact_snippets": "Bilateral breast conserving surgery",
                    "criterion": "breast conserving surgery",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Invasive lobular carcinoma, DCIS, LCIS",
            "criterions": [
                {
                    "exact_snippets": "Invasive lobular carcinoma",
                    "criterion": "invasive lobular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "DCIS",
                    "criterion": "DCIS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LCIS",
                    "criterion": "LCIS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Suspicion of extensive DCIS component of NST tumor",
            "criterions": [
                {
                    "exact_snippets": "Suspicion of extensive DCIS component",
                    "criterion": "DCIS component",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "NST tumor",
                    "criterion": "NST tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Diagnosis of recurrent breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of recurrent breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Previous radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient is pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Patient is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator",
            "criterions": [
                {
                    "exact_snippets": "Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant)",
                    "criterion": "active implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator",
                    "criterion": "passive implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "allowed at the discretion of the principal investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation",
            "criterions": [
                {
                    "exact_snippets": "not able to follow study protocol (e.g., due to cognitive disease)",
                    "criterion": "ability to follow study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation",
                    "criterion": "ability to understand clinical investigation",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}