{
    "info": {
        "nct_id": "NCT03308682",
        "official_title": "Safety and Dosimetry of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors",
        "inclusion_criteria": "* Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Adults",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neuroendocrine tumors",
                    "criterion": "neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had metastasized",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inoperable",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "RECIST criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "well-differentiated histologic features",
                    "criterion": "histologic differentiation",
                    "requirements": [
                        {
                            "requirement_type": "differentiation",
                            "expected_value": "well-differentiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ki67 index of 0 to 20%",
                    "criterion": "Ki67 index",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 20,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "68Ga-DOTA-TATE PET/CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed somatostatin receptor-expressing",
                    "criterion": "somatostatin receptor expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging",
                    "criterion": "lesion uptake",
                    "requirements": [
                        {
                            "requirement_type": "uptake",
                            "expected_value": "higher than normal liver parenchyma"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 weeks",
                    "criterion": "imaging timeframe",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine level of more than 150 μmol per liter",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "μmol per liter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline measured GFR of less than 50 mL/min/1.73 m2",
                    "criterion": "baseline measured GFR",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin level of less than 8.0 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 8.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "white-cell count of less than 2.0× 109/L",
                    "criterion": "white-cell count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "× 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count of less than 75 × 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 75,
                                "unit": "× 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin level of more than 3 times the upper limit of the normal range",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "more than 3 times the upper limit of the normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum albumin level of more than 3.0 g per deciliter",
                    "criterion": "serum albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "g per deciliter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac insufficiency including carcinoid heart valve disease",
                    "criterion": "cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe allergy or hypersensitivity to radiographic contrast material",
                    "criterion": "severe allergy or hypersensitivity to radiographic contrast material",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy or breastfeeding",
                    "criterion": "pregnancy or breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}