{
    "info": {
        "nct_id": "NCT01806558",
        "official_title": "Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions",
        "inclusion_criteria": "* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:\n\n  1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound.\n  2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size.\n  3. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 40 Years",
        "exclusion_criteria": "1. Are unable to understand and sign the consent form\n2. Are pregnant or lactating\n3. Are physically unable to sit upright and still for 40 minutes\n4. Have undergone bilateral mastectomy\n5. Are not scheduled to undergo conventional ultrasound",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "women"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "age 40 and older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 40
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound.",
            "criterions": [
                {
                    "exact_snippets": [
                        "finding of a mass lesion on mammography or breast MRI"
                    ],
                    "criterion": "mass lesion",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "BIRADS 0, 4 or 5"
                    ],
                    "criterion": "BIRADS category",
                    "requirement_type": "category",
                    "expected_value": [
                        "0",
                        "4",
                        "5"
                    ]
                },
                {
                    "exact_snippets": [
                        ">0.5 cm",
                        "< 2 cm"
                    ],
                    "criterion": "mass lesion size",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 0.5
                            },
                            {
                                "operator": "<",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "has had or will have additional workup with focused ultrasound"
                    ],
                    "criterion": "additional workup with focused ultrasound",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size.",
            "criterions": [
                {
                    "exact_snippets": [
                        "finding of a mass lesion on ultrasound"
                    ],
                    "criterion": "mass lesion",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "BIRADS 0, 4 or 5"
                    ],
                    "criterion": "BIRADS category",
                    "requirement_type": "category",
                    "expected_value": [
                        "0",
                        "4",
                        "5"
                    ]
                },
                {
                    "exact_snippets": [
                        "> 0.5 cm",
                        "< 2 cm"
                    ],
                    "criterion": "mass lesion size",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 0.5
                            },
                            {
                                "operator": "<",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "3. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound.",
            "criterions": [
                {
                    "exact_snippets": [
                        "positive finding on MBI"
                    ],
                    "criterion": "MBI finding",
                    "requirement_type": "result",
                    "expected_value": "positive"
                },
                {
                    "exact_snippets": [
                        "MBI that is < 2 cm in size"
                    ],
                    "criterion": "MBI finding size",
                    "requirement_type": "size",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "requires additional diagnostic workup with focused ultrasound"
                    ],
                    "criterion": "diagnostic workup",
                    "requirement_type": "necessity",
                    "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 40 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 40
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Are unable to understand and sign the consent form",
            "criterions": [
                {
                    "exact_snippets": [
                        "unable to understand"
                    ],
                    "criterion": "understanding",
                    "requirement_type": "ability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "sign the consent form"
                    ],
                    "criterion": "consent form",
                    "requirement_type": "signing ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Are pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": [
                        "Are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Are physically unable to sit upright and still for 40 minutes",
            "criterions": [
                {
                    "exact_snippets": [
                        "physically unable to sit upright and still for 40 minutes"
                    ],
                    "criterion": "ability to sit upright and still",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": "<",
                        "value": 40
                    }
                }
            ]
        },
        {
            "line": "4. Have undergone bilateral mastectomy",
            "criterions": [
                {
                    "exact_snippets": [
                        "undergone bilateral mastectomy"
                    ],
                    "criterion": "bilateral mastectomy",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Are not scheduled to undergo conventional ultrasound",
            "criterions": [
                {
                    "exact_snippets": [
                        "scheduled to undergo conventional ultrasound"
                    ],
                    "criterion": "conventional ultrasound",
                    "requirement_type": "scheduled",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}