{
    "info": {
        "nct_id": "NCT05880394",
        "official_title": "Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer",
        "inclusion_criteria": "* Age of at least 18 years at the time of signing the informed consent.\n* Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.\n* For women of childbearing potential (WOCBP):\n\n  a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).\n* Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE\n* Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.\n* Unable to perform PET/CT scans according to technical specifications and local guidelines.\n* Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.\n* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.\n* Unable or unwilling to comply with the requirements of the study protocol.\n* Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age of at least 18 years at the time of signing the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Age of at least 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy proven",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "proven",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ER+",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 any",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically progressive",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "clinical status",
                            "expected_value": "progressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IV breast cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring restaging",
                    "criterion": "restaging requirement",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For women of childbearing potential (WOCBP):",
            "criterions": [
                {
                    "exact_snippets": "women of childbearing potential (WOCBP)",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).",
            "criterions": [
                {
                    "exact_snippets": "Negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 48 hours of Ga-68-DOTATATE injection",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 48,
                                "unit": "hours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "post-menarchal",
                    "criterion": "menstrual status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-menarchal"
                        }
                    ]
                },
                {
                    "exact_snippets": "has not reached postmenopausal state",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 12 continuous months of amenorrhea",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no identified cause other than menopause",
                    "criterion": "cause of amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "menopause"
                        }
                    ]
                },
                {
                    "exact_snippets": "has not undergone surgical sterilization",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy",
                    "criterion": "type of surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "total hysterectomy",
                                "bilateral tubal ligation",
                                "bilateral oophorectomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 weeks before taking study drug",
                    "criterion": "timing of surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "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 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": "* Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.",
            "criterions": [
                {
                    "exact_snippets": "Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent)",
                    "criterion": "glucocorticoid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mg prednisone daily"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "long acting SSA within the last 28 days",
                    "criterion": "long acting SSA usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "short acting SSA that cannot be interrupted for 24 hours",
                    "criterion": "short acting SSA interruption",
                    "requirements": [
                        {
                            "requirement_type": "interruption ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to perform PET/CT scans according to technical specifications and local guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Unable to perform PET/CT scans",
                    "criterion": "PET/CT scan capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent primary malignancy",
                    "criterion": "concurrent primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated carcinoma in situ",
                    "criterion": "adequately treated carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma carcinoma of the skin",
                    "criterion": "non-melanoma carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated malignancy ... complete response ... not expected to require treatment for recurrence during participation in the study",
                    "criterion": "curatively treated malignancy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.",
            "criterions": [
                {
                    "exact_snippets": "Current somatic or psychiatric disease/condition",
                    "criterion": "somatic disease/condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Current somatic or psychiatric disease/condition",
                    "criterion": "psychiatric disease/condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to comply with the requirements of the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to comply with the requirements of the study protocol.",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.",
            "criterions": [
                {
                    "exact_snippets": "Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.",
                    "criterion": "prior participation in interventional clinical study",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to Gallium-68 DOTATATE",
                    "criterion": "hypersensitivity to Gallium-68 DOTATATE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to Copper-64 DOTATATE",
                    "criterion": "hypersensitivity to Copper-64 DOTATATE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... octreotate",
                    "criterion": "hypersensitivity to octreotate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of Gallium-68 DOTATATE",
                    "criterion": "hypersensitivity to excipients of Gallium-68 DOTATATE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of ... Copper-64 DOTATATE",
                    "criterion": "hypersensitivity to excipients of Copper-64 DOTATATE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}