{
    "info": {
        "nct_id": "NCT05069220",
        "official_title": "A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.",
        "inclusion_criteria": "- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor.\n\nFor patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit.\n\nThe subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol.\nHealthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 80 Years",
        "exclusion_criteria": "- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.\n\nPatients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor.",
            "criterions": [
                {
                    "exact_snippets": "The subject has read, signed, and dated an informed consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with histologically confirmed or clinically suspicious neural crest tumor",
                    "criterion": "neural crest tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically confirmed",
                                "clinically suspicious"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "For patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit.",
            "criterions": [
                {
                    "exact_snippets": "patients with neuroblastoma",
                    "criterion": "neuroblastoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT)",
                    "criterion": "123I-MIBG scintigraphy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "planar",
                                "SPECT/CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 6 months prior to the inclusion visit",
                    "criterion": "123I-MIBG scintigraphy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled within 3 months after the inclusion visit",
                    "criterion": "123I-MIBG scintigraphy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "The subject is male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "nonpregnant, nonlactating female",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "nonpregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "nonpregnant, nonlactating female",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "nonlactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterile",
                    "criterion": "fertility status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "post-menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "The subject is able and willing to comply with all study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "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 have minimum age of 1 Year",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 1 Year",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "potentially pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "potentially pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.",
            "criterions": [
                {
                    "exact_snippets": "undergo surgery between the selection and inclusion visit",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "between selection and inclusion visit"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may possibly be pregnant",
                    "criterion": "possible pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "wish (including their partners) to become pregnant during the study period",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not suitable to participate in the trial according to researchers",
                    "criterion": "suitability according to researchers",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}