{
    "info": {
        "nct_id": "NCT01396382",
        "official_title": "Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors",
        "inclusion_criteria": "* Known diagnosis of neuroendocrine tumor\n* At least 18 years of age\n* Able to provide informed consent\n* Karnofsky score greater than 50\n* Females of childbearing potential must have a negative pregnancy test at screening/baseline\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Serum creatinine >3.0 mg/dL (270 μM/L)\n* Hepatic enzyme levels more than 5 times upper limit of normal.\n* Known severe allergy or hypersensitivity to IV radiographic contrast.\n* Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.\n* Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.\n* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).\n* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)\n* Recognized concurrent active infection\n* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Known diagnosis of neuroendocrine tumor",
            "criterions": [
                {
                    "exact_snippets": "Known diagnosis of neuroendocrine tumor",
                    "criterion": "neuroendocrine tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky score greater than 50",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky score greater than 50",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females of childbearing potential must have a negative pregnancy test at screening/baseline",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test at screening/baseline",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Serum creatinine >3.0 mg/dL (270 μM/L)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine >3.0 mg/dL (270 μM/L)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic enzyme levels more than 5 times upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "Hepatic enzyme levels more than 5 times upper limit of normal.",
                    "criterion": "hepatic enzyme levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known severe allergy or hypersensitivity to IV radiographic contrast.",
            "criterions": [
                {
                    "exact_snippets": "Known severe allergy or hypersensitivity to IV radiographic contrast.",
                    "criterion": "severe allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "IV radiographic contrast"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.",
            "criterions": [
                {
                    "exact_snippets": "Use of any other investigational product or device within 30 days prior to dosing",
                    "criterion": "use of investigational product or device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known requirement for any other investigational agent prior to completion of all scheduled study assessments",
                    "criterion": "requirement for investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.",
            "criterions": [
                {
                    "exact_snippets": "body weight of 400 pounds or more",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 400,
                                "unit": "pounds"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to enter the bore of the PET/CT scanner due to BMI",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "ability to enter PET/CT scanner",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).",
            "criterions": [
                {
                    "exact_snippets": "Inability to lie still for the entire imaging time",
                    "criterion": "ability to lie still",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Inability to complete the needed investigational and standard-of-care imaging examinations",
                    "criterion": "ability to complete imaging examinations",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation phobia",
                    "criterion": "radiation phobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recognized concurrent active infection",
            "criterions": [
                {
                    "exact_snippets": "concurrent active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.",
            "criterions": [
                {
                    "exact_snippets": "Any additional medical condition",
                    "criterion": "additional medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious intercurrent illness",
                    "criterion": "serious intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other extenuating circumstance",
                    "criterion": "extenuating circumstance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}