{
    "info": {
        "nct_id": "NCT00816582",
        "official_title": "A Phase II Clinical Trial to Evaluate 18F-Fluoroestradiol Positron Emission Tomography / Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer",
        "inclusion_criteria": "* post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)\n* hormone receptor positive (ER and/or PgR) disease as determined locally\n* WHO performance status 0-2\n* life expectancy of ≥ 3 months\n* the presence of at least one measurable or evaluable (non-measurable) lesion\n* informed consent prior to any study procedures\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 45 Years",
        "exclusion_criteria": "* life threatening metastatic visceral disease\n* brain or leptomeningeal metastases\n* prior exposure to fulvestrant\n* history of bleeding diathesis or need for long term anti-coagulation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)",
            "criterions": [
                {
                    "exact_snippets": "post-menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 60 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥ 45 years with amenorrhea for > 12 months",
                    "criterion": "age with amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle stimulating hormone and estrogen levels within post-menopausal range",
                    "criterion": "hormone levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "post-menopausal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior bilateral oophorectomy",
                    "criterion": "surgical history",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "bilateral oophorectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hormone receptor positive (ER and/or PgR) disease as determined locally",
            "criterions": [
                {
                    "exact_snippets": "hormone receptor positive (ER and/or PgR) disease",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status 0-2",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy of ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* the presence of at least one measurable or evaluable (non-measurable) lesion",
            "criterions": [
                {
                    "exact_snippets": "the presence of at least one measurable or evaluable (non-measurable) lesion",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable (non-measurable)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* informed consent prior to any study procedures",
            "criterions": [
                {
                    "exact_snippets": "informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 45 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* life threatening metastatic visceral disease",
            "criterions": [
                {
                    "exact_snippets": "life threatening metastatic visceral disease",
                    "criterion": "metastatic visceral disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "life threatening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* brain or leptomeningeal metastases",
            "criterions": [
                {
                    "exact_snippets": "brain ... metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal metastases",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior exposure to fulvestrant",
            "criterions": [
                {
                    "exact_snippets": "prior exposure to fulvestrant",
                    "criterion": "fulvestrant exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* history of bleeding diathesis or need for long term anti-coagulation",
            "criterions": [
                {
                    "exact_snippets": "history of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need for long term anti-coagulation",
                    "criterion": "anti-coagulation",
                    "requirements": [
                        {
                            "requirement_type": "need",
                            "expected_value": "long term"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}