{
    "info": {
        "nct_id": "NCT02638935",
        "official_title": "Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions: Can Patient Selection for Biopsy be Improved? - A Confirmatory Multi-Center-Study",
        "inclusion_criteria": "* Female\n* Age ≥18 years\n* Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound\n* Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine\n* Signed informed consent of study participation\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or lactating women\n* Women with breast implants on the same side as the lesion\n* Women that underwent local radiation or chemotherapy within the last 12 months\n* Women with history of breast cancer or breast surgery in the same quadrant\n* Lesions in or close to scar tissue (< 1cm)\n* Skin lesions or lesions that have been biopsied previously\n* Lesion larger than 4 cm in the longest dimension\n* No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Female",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Female"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specificity",
                        "expected_value": "female"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Female"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specificity",
                        "expected_value": "female"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥18 years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Age ≥18 years"
                        ],
                        "criterion": "age",
                        "requirement_type": "N/A",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 18
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Age ≥18 years"
                        ],
                        "criterion": "age",
                        "requirement_type": "N/A",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 18
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound",
                "criterions": [
                    {
                        "exact_snippets": [
                            "lesion ≥ 0.5 cm in largest diameter size"
                        ],
                        "criterion": "lesion size",
                        "requirement_type": "minimum size",
                        "expected_value": {
                            "operator": ">=",
                            "value": 0.5
                        }
                    },
                    {
                        "exact_snippets": [
                            "initially scored BI-RADS® 3, 4a, 4b or 4c"
                        ],
                        "criterion": "BI-RADS score",
                        "requirement_type": "initial score",
                        "expected_value": [
                            "3",
                            "4a",
                            "4b",
                            "4c"
                        ]
                    },
                    {
                        "exact_snippets": [
                            "B-mode ultrasound"
                        ],
                        "criterion": "imaging modality",
                        "requirement_type": "type",
                        "expected_value": "B-mode ultrasound"
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "lesion ≥ 0.5 cm in largest diameter size"
                        ],
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                        "expected_value": {
                            "operator": ">=",
                            "value": 0.5
                        }
                    },
                    {
                        "exact_snippets": [
                            "initially scored BI-RADS® 3, 4a, 4b or 4c"
                        ],
                        "criterion": "BI-RADS score",
                        "requirement_type": "initial score",
                        "expected_value": [
                            "3",
                            "4a",
                            "4b",
                            "4c"
                        ]
                    },
                    {
                        "exact_snippets": [
                            "B-mode ultrasound"
                        ],
                        "criterion": "imaging modality",
                        "requirement_type": "type",
                        "expected_value": "B-mode ultrasound"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine",
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                    {
                        "exact_snippets": [
                            "Informed consent about histological examination"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "core cut biopsy (CCB)"
                        ],
                        "criterion": "core cut biopsy",
                        "requirement_type": "informed consent",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "vacuum-assisted biopsy (VAB)"
                        ],
                        "criterion": "vacuum-assisted biopsy",
                        "requirement_type": "informed consent",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "fine needle aspiration (FNA)"
                        ],
                        "criterion": "fine needle aspiration",
                        "requirement_type": "informed consent",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "surgery"
                        ],
                        "criterion": "surgery",
                        "requirement_type": "informed consent",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "or_criteria": [
                            {
                                "exact_snippets": [
                                    "core cut biopsy (CCB)"
                                ],
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                                "requirement_type": "informed consent",
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                            },
                            {
                                "exact_snippets": [
                                    "vacuum-assisted biopsy (VAB)"
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                                "criterion": "vacuum-assisted biopsy",
                                "requirement_type": "informed consent",
                                "expected_value": true
                            },
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                                "exact_snippets": [
                                    "fine needle aspiration (FNA)"
                                ],
                                "criterion": "fine needle aspiration",
                                "requirement_type": "informed consent",
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                            },
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                                    "surgery"
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                                "requirement_type": "informed consent",
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                    },
                    {
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                            "Informed consent about histological examination"
                        ],
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
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                "line": "* Signed informed consent of study participation",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Signed informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Signed informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
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                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
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                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Must be FEMALE"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specific value",
                        "expected_value": "female"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Must be FEMALE"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specific value",
                        "expected_value": "female"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 18
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 18
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Pregnant or lactating women",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "lactating"
                        ],
                        "criterion": "lactation",
                        "requirement_type": "status",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lactating"
                        ],
                        "criterion": "lactation",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women with breast implants on the same side as the lesion",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Women"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specificity",
                        "expected_value": "female"
                    },
                    {
                        "exact_snippets": [
                            "breast implants"
                        ],
                        "criterion": "breast implants",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "same side as the lesion"
                        ],
                        "criterion": "implant location relative to lesion",
                        "requirement_type": "specificity",
                        "expected_value": "same side"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": [
                            "Women"
                        ],
                        "criterion": "gender",
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                    },
                    {
                        "exact_snippets": [
                            "breast implants"
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                        "criterion": "breast implants",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "same side as the lesion"
                        ],
                        "criterion": "implant location relative to lesion",
                        "requirement_type": "specificity",
                        "expected_value": "same side"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women that underwent local radiation or chemotherapy within the last 12 months",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Women"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specificity",
                        "expected_value": "female"
                    },
                    {
                        "exact_snippets": [
                            "underwent local radiation"
                        ],
                        "criterion": "local radiation",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
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                            "underwent",
                            "chemotherapy"
                        ],
                        "criterion": "chemotherapy",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "within the last 12 months"
                        ],
                        "criterion": "treatment timing",
                        "requirement_type": "recency",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 12
                                }
                            ]
                        }
                    }
                ]
            },
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                            "exact_snippets": [
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                            ],
                            "criterion": "gender",
                            "requirement_type": "specificity",
                            "expected_value": "female"
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                                {
                                    "exact_snippets": [
                                        "underwent local radiation"
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                                    "criterion": "local radiation",
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                                        "chemotherapy"
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                "then_criteria": {
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                    ],
                    "criterion": "treatment timing",
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                                "operator": "<=",
                                "value": 12
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Women with history of breast cancer or breast surgery in the same quadrant",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Women"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specific",
                        "expected_value": "female"
                    },
                    {
                        "exact_snippets": [
                            "history of breast cancer"
                        ],
                        "criterion": "breast cancer",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "breast surgery in the same quadrant"
                        ],
                        "criterion": "breast surgery",
                        "requirement_type": "location",
                        "expected_value": "same quadrant"
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Women"
                                ],
                                "criterion": "gender",
                                "requirement_type": "specific",
                                "expected_value": "female"
                            },
                            {
                                "exact_snippets": [
                                    "history of breast cancer"
                                ],
                                "criterion": "breast cancer",
                                "requirement_type": "history",
                                "expected_value": true
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                    },
                    {
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                            {
                                "exact_snippets": [
                                    "Women"
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                                "requirement_type": "specific",
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                            },
                            {
                                "exact_snippets": [
                                    "breast surgery in the same quadrant"
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                                "requirement_type": "location",
                                "expected_value": "same quadrant"
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lesions in or close to scar tissue (< 1cm)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Lesions"
                        ],
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                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "close to scar tissue (< 1cm)"
                        ],
                        "criterion": "scar tissue proximity",
                        "requirement_type": "distance",
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                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 1
                                }
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                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Lesions"
                        ],
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                    {
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                                {
                                    "operator": "<",
                                    "value": 1
                                }
                            ]
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Skin lesions or lesions that have been biopsied previously",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Skin lesions"
                        ],
                        "criterion": "skin lesions",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lesions that have been biopsied previously"
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                        "requirement_type": "biopsy history",
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                            "Skin lesions"
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                            "lesions that have been biopsied previously"
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                        "requirement_type": "biopsy history",
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                    }
                ]
            }
        },
        {
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                "line": "* Lesion larger than 4 cm in the longest dimension",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Lesion larger than 4 cm in the longest dimension"
                        ],
                        "criterion": "lesion size",
                        "requirement_type": "dimension",
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                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 4
                                }
                            ]
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                            {
                                "operator": ">",
                                "value": 4
                            }
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        },
        {
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                "line": "* No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.",
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                            "lesion"
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                                {
                                    "operator": ">",
                                    "value": 50
                                }
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                        ],
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                                {
                                    "operator": ">",
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                                }
                            ]
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                ]
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        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}