{
    "info": {
        "nct_id": "NCT01237457",
        "official_title": "177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms",
        "inclusion_criteria": "* Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)\n* Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.\n* Life Expectancy greater than 12 weeks.\n* Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.\n* Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).\n* Total Bilirubin ≤ 3X UNL.\n* Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.\n* All patients must have a Karnofsky performance status of at least 60%\n* Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Possible surgery with curative intent.\n* Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.\n* Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.\n* Uncontrolled congestive heart failure.\n* Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).\n* Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study\n* Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.\n* In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up.\n* Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.\n* Prior radiation therapy to more than 25% of the bone marrow.\n* Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)",
                    "criterion": "Gastroenteropancreatic (GEP) tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.",
            "criterions": [
                {
                    "exact_snippets": "Presence of somatostatin-receptors on the known tumor lesions",
                    "criterion": "somatostatin-receptors on tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy",
                    "criterion": "OctreoScan demonstration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months of the first dose of radiolabelled octreotate therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging",
                    "criterion": "OctreoScan uptake",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "normal liver uptake"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life Expectancy greater than 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life Expectancy greater than 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 150,
                                        "unit": "µmol/liter"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.7,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured creatinine clearance ... ≥ 50ML/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ML/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured GFR using plasma clearance methods, not gamma camera based",
                    "criterion": "GFR measurement method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "plasma clearance methods"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL)",
                    "criterion": "hemoglobin concentration",
                    "requirements": [
                        {
                            "requirement_type": "concentration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5.5,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "WBC ≥ 2*109/L (2000/mm3)",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "*109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 100*109/L (100*103/mm3)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "*109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Bilirubin ≤ 3X UNL.",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin ≤ 3X UNL.",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.",
            "criterions": [
                {
                    "exact_snippets": "Serum Albumin > 30g/L",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum albumin ≤ 30g/L ... normal prothrombin time",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal prothrombin time",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have a Karnofsky performance status of at least 60%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status of at least 60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis",
            "criterions": [
                {
                    "exact_snippets": "Patients must be greater than 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Possible surgery with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "Possible surgery with curative intent.",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.",
            "criterions": [
                {
                    "exact_snippets": "Surgery ... within 3 months of the start of therapy.",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy ... within 3 months of the start of therapy.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy ... within 3 months of the start of therapy.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other investigational therapy within 3 months of the start of therapy.",
                    "criterion": "other investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.",
            "criterions": [
                {
                    "exact_snippets": "known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastases have been treated and stabilized for at least 6 months prior to study start",
                    "criterion": "treated and stabilized brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of brain metastases ... head CT with contrast to document stable disease prior to study start",
                    "criterion": "head CT with contrast",
                    "requirements": [
                        {
                            "requirement_type": "documentation of stable disease",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled congestive heart failure.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).",
            "criterions": [
                {
                    "exact_snippets": "taking concomitant medications which decrease renal function",
                    "criterion": "concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "effect on renal function",
                            "expected_value": "decrease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study",
            "criterions": [
                {
                    "exact_snippets": "Any subject receiving therapy with somatostatin analogues",
                    "criterion": "therapy with somatostatin analogues",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the dose has been stable for at least 3 months prior to the first cycle in this study",
                    "criterion": "dose stability of somatostatin analogues",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the disease status during these 4 months has been documented by modified RECISTS criteria",
                    "criterion": "disease status documentation by modified RECISTS criteria",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.",
            "criterions": [
                {
                    "exact_snippets": "Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues",
                    "criterion": "short acting somatostatin analogue therapy",
                    "requirements": [
                        {
                            "requirement_type": "interruption ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues",
                    "criterion": "long-acting somatostatin analogue therapy",
                    "requirements": [
                        {
                            "requirement_type": "interruption ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging",
                    "criterion": "Octreoscan uptake",
                    "requirements": [
                        {
                            "requirement_type": "comparison to normal liver uptake",
                            "expected_value": "at least as high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up.",
            "criterions": [
                {
                    "exact_snippets": "unusual hematological parameters",
                    "criterion": "hematological parameters",
                    "requirements": [
                        {
                            "requirement_type": "unusual",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increased MCV (>105fL)",
                    "criterion": "MCV",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 105,
                                "unit": "fL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "previous chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.",
            "criterions": [
                {
                    "exact_snippets": "another significant medical ... currently uncontrolled by treatment",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "another significant ... psychiatric ... currently uncontrolled by treatment",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "another significant ... surgical condition, currently uncontrolled by treatment",
                    "criterion": "surgical condition",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy to more than 25% of the bone marrow.",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy to more than 25% of the bone marrow.",
                    "criterion": "radiation therapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment",
            "criterions": [
                {
                    "exact_snippets": "Female patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days",
                    "criterion": "contraceptive use in women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days",
                    "criterion": "contraceptive use or abstinence in male patients with female partners of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}