{
    "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": [
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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"
                }
            ]
        },
        {
            "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",
            "criterions": [
                {
                    "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
                }
            ]
        },
        {
            "line": "* Signed informed consent of study participation",
            "criterions": [
                {
                    "exact_snippets": [
                        "Signed informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "signed",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be FEMALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "female"
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "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
                }
            ]
        },
        {
            "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"
                }
            ]
        },
        {
            "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
                },
                {
                    "exact_snippets": [
                        "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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"
                }
            ]
        },
        {
            "line": "* Lesions in or close to scar tissue (< 1cm)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Lesions"
                    ],
                    "criterion": "lesions",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "close to scar tissue (< 1cm)"
                    ],
                    "criterion": "scar tissue proximity",
                    "requirement_type": "distance",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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"
                    ],
                    "criterion": "lesions",
                    "requirement_type": "biopsy history",
                    "expected_value": true
                }
            ]
        },
        {
            "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",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.",
            "criterions": [
                {
                    "exact_snippets": [
                        "lesion"
                    ],
                    "criterion": "lesion",
                    "requirement_type": "inclusion",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "more than 50% of the lesion is further down than 4 cm beneath the skin level"
                    ],
                    "criterion": "lesion depth",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 50
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}