{
    "info": {
        "nct_id": "NCT01879657",
        "official_title": "An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)",
        "inclusion_criteria": "* Signed informed consent\n* Subjects of either sex, aged ≥18 years\n* Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day\n* Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULN for total bilirubin is 1.3mg/dL]\n* Serum creatinine: Serum creatinine: <170 μmol/L\n* egative pregnancy test in women capable of child-bearing\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE\n* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug\n* Pregnant or breast-feeding women\n* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects of either sex, aged ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Subjects of either sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day",
            "criterions": [
                {
                    "exact_snippets": "Histologically and/or clinically confirmed and/or suspected NET",
                    "criterion": "NET (Neuroendocrine Tumor)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "clinically",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc.",
                    "criterion": "diagnostic imaging study",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "FDG PET/CT",
                                "NaF PET/CT",
                                "bone scan",
                                "ultrasound"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "of the tumor region or suspected area within the 4 weeks of dosing day",
                    "criterion": "timing of diagnostic imaging",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULN for total bilirubin is 1.3mg/dL]",
            "criterions": [
                {
                    "exact_snippets": "WBC: ≥2 x 109/L",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Haemoglobin: ≥8.0 g/dL",
                    "criterion": "Haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets: ≥50 x 109/L",
                    "criterion": "Platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively]",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 350,
                                "unit": "Units/I"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively]",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Units/I"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively]",
                    "criterion": "AP",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Units/I"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin: ≤3 times ULN [ULN for total bilirubin is 1.3mg/dL]",
                    "criterion": "Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.9,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine: Serum creatinine: <170 μmol/L",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine: <170 μmol/L",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 170,
                                "unit": "μmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to DOTA",
                    "criterion": "hypersensitivity to DOTA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to 68Gallium",
                    "criterion": "hypersensitivity to 68Gallium",
                    "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 68Ga-DOTATATE",
                    "criterion": "hypersensitivity to excipients of 68Ga-DOTATATE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging.",
                    "criterion": "therapeutic use of somatostatin analogue",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging.",
                    "criterion": "therapeutic use of Sandostatin®",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug",
                    "criterion": "wash-out phase for Sandostatin® LAR",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 or psychiatric disease/condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* egative pregnancy test in women capable of child-bearing",
            "criterions": [
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women capable of child-bearing",
                    "criterion": "child-bearing capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}