{
    "info": {
        "nct_id": "NCT01067976",
        "official_title": "An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist®) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI",
        "inclusion_criteria": "* Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.\n* If female, a digital XRM is required if any of the following criteria is met:\n\n  1. patient is younger than 50 years;\n  2. patient has heterogeneously or extremely dense breasts;\n  3. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).\n* If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.\n* Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Is a female patient who is pregnant or lactating\n* Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.\n* Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.\n* Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).\n* Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).\n* Has received chemotherapy or hormonal therapy for breast cancer within 6 months.\n* Has received hormone replacement therapy within 4 weeks prior to study drug administration.\n* Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application\n* Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.",
            "criterions": [
                {
                    "exact_snippets": "Recent histologically proven diagnosis of breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained X-Ray Mammography (XRM) of both breasts",
                    "criterion": "X-Ray Mammography",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "both breasts"
                        }
                    ]
                },
                {
                    "exact_snippets": "according to American College of Radiology [ACR]",
                    "criterion": "X-Ray Mammography standard",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "American College of Radiology [ACR]"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed no longer than 6 weeks prior to enrollment into the study",
                    "criterion": "X-Ray Mammography timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast",
                    "criterion": "Magnetic Resonance Mammography referral",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, a digital XRM is required if any of the following criteria is met:",
            "criterions": [
                {
                    "exact_snippets": "If female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "a digital XRM is required",
                    "criterion": "digital XRM",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. patient is younger than 50 years;",
            "criterions": [
                {
                    "exact_snippets": "patient is younger than 50 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. patient has heterogeneously or extremely dense breasts;",
            "criterions": [
                {
                    "exact_snippets": "heterogeneously or extremely dense breasts",
                    "criterion": "breast density",
                    "requirements": [
                        {
                            "requirement_type": "density",
                            "expected_value": [
                                "heterogeneously dense",
                                "extremely dense"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).",
            "criterions": [
                {
                    "exact_snippets": "is not post-menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "post-menopause defined as at least 12 months prior to inclusion without menstruation",
                    "criterion": "post-menopause definition",
                    "requirements": [
                        {
                            "requirement_type": "duration without menstruation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.",
            "criterions": [
                {
                    "exact_snippets": "If female of childbearing potential",
                    "criterion": "female of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "true"
                        }
                    ]
                },
                {
                    "exact_snippets": "MRM should be performed on the 7-14th day of the menstrual cycle",
                    "criterion": "MRM timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "7-14th day of the menstrual cycle"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2",
                    "criterion": "estimated glomerular filtration rate (eGFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73m^2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine result within 2 weeks prior to study enrollment",
                    "criterion": "serum creatinine result",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks prior to study enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Is a female patient who is pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.",
            "criterions": [
                {
                    "exact_snippets": "Has any contraindication to the MRM examination (e.g. metal implants, phobia)",
                    "criterion": "contraindication to the MRM examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to ... the use of gadolinium-containing contrast agents",
                    "criterion": "contraindication to the use of gadolinium-containing contrast agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.",
            "criterions": [
                {
                    "exact_snippets": "Has received any contrast agent within 24 hours prior to the study MRM",
                    "criterion": "contrast agent administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 24 hours prior to the study MRM"
                        }
                    ]
                },
                {
                    "exact_snippets": "is scheduled to receive any contrast agent within 24 hours after the study MRM",
                    "criterion": "contrast agent administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 24 hours after the study MRM"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).",
            "criterions": [
                {
                    "exact_snippets": "severe cardiovascular disease",
                    "criterion": "severe cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known long QT syndrome",
                    "criterion": "long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myocardial infarction [< 14 days]",
                    "criterion": "acute myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure New York Heart Association class IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "New York Heart Association class IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute stroke (< 48 hours)",
                    "criterion": "acute stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 48,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).",
            "criterions": [
                {
                    "exact_snippets": "acute renal insufficiency ... due to hepato-renal syndrome",
                    "criterion": "acute renal insufficiency due to hepato-renal syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute renal insufficiency ... in the peri-operative liver transplantation period",
                    "criterion": "acute renal insufficiency in the peri-operative liver transplantation period",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute ... moderate or severe renal insufficiency",
                    "criterion": "acute moderate or severe renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic moderate or severe renal insufficiency",
                    "criterion": "chronic moderate or severe renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "glomerular filtration rate < 60 mL/min/1.73m^2",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min/1.73m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received chemotherapy or hormonal therapy for breast cancer within 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Has received chemotherapy ... within 6 months.",
                    "criterion": "chemotherapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received ... hormonal therapy for breast cancer within 6 months.",
                    "criterion": "hormonal therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received hormone replacement therapy within 4 weeks prior to study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Has received hormone replacement therapy within 4 weeks prior to study drug administration.",
                    "criterion": "hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application",
            "criterions": [
                {
                    "exact_snippets": "scheduled or likely to require a surgery",
                    "criterion": "surgery requirement",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled or likely to require a ... biopsy",
                    "criterion": "biopsy requirement",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM",
            "criterions": [
                {
                    "exact_snippets": "prior excisional biopsy or breast surgery",
                    "criterion": "prior excisional biopsy or breast surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "between XRM and study MRM",
                    "criterion": "timing of excisional biopsy or breast surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "between XRM and study MRM"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}