{
    "info": {
        "nct_id": "NCT02106598",
        "official_title": "Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases",
        "inclusion_criteria": "* 18 years of age or older\n* Histologically confirmed diagnosis of melanoma at MSKCC\n* Have one of the following disease histories:\n* Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, oral cavity squamous cell carcinoma, and squamous cell carcinoma of the skin patients in whom SLN mapping is indicated\n\n  * Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas\n  * Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.\n  * Newly diagnosed patients with previous excisional biopsy.\n* At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation\n* At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.\n* At the discretion of the physician or surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).\n* For melanoma patients, if patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.\n* All patients of childbearing and child-creating age must be using an acceptable form of birth control\n* Women who are pre-menopausal must have a negative serum pregnancy test\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known pregnancy or breast-feeding.\n* Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": [
                        "18 years of age or older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of melanoma at MSKCC",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologically confirmed diagnosis of melanoma"
                    ],
                    "criterion": "melanoma",
                    "requirement_type": "diagnosis confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "at MSKCC"
                    ],
                    "criterion": "diagnosis location",
                    "requirement_type": "location",
                    "expected_value": "MSKCC"
                }
            ]
        },
        {
            "line": "* Have one of the following disease histories:",
            "criterions": [
                {
                    "exact_snippets": [
                        "one of the following disease histories"
                    ],
                    "criterion": "disease history",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, oral cavity squamous cell carcinoma, and squamous cell carcinoma of the skin patients in whom SLN mapping is indicated",
            "criterions": [
                {
                    "exact_snippets": [
                        "Newly-diagnosed or recurrent"
                    ],
                    "criterion": "malignant melanoma",
                    "requirement_type": "diagnosis status",
                    "expected_value": [
                        "newly-diagnosed",
                        "recurrent"
                    ]
                },
                {
                    "exact_snippets": [
                        "local, regional, metastatic"
                    ],
                    "criterion": "malignant melanoma",
                    "requirement_type": "stage",
                    "expected_value": [
                        "local",
                        "regional",
                        "metastatic"
                    ]
                },
                {
                    "exact_snippets": [
                        "Newly-diagnosed or recurrent"
                    ],
                    "criterion": "oral cavity squamous cell carcinoma",
                    "requirement_type": "diagnosis status",
                    "expected_value": [
                        "newly-diagnosed",
                        "recurrent"
                    ]
                },
                {
                    "exact_snippets": [
                        "local, regional, metastatic"
                    ],
                    "criterion": "oral cavity squamous cell carcinoma",
                    "requirement_type": "stage",
                    "expected_value": [
                        "local",
                        "regional",
                        "metastatic"
                    ]
                },
                {
                    "exact_snippets": [
                        "Newly-diagnosed or recurrent"
                    ],
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirement_type": "diagnosis status",
                    "expected_value": [
                        "newly-diagnosed",
                        "recurrent"
                    ]
                },
                {
                    "exact_snippets": [
                        "local, regional, metastatic"
                    ],
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirement_type": "stage",
                    "expected_value": [
                        "local",
                        "regional",
                        "metastatic"
                    ]
                },
                {
                    "exact_snippets": [
                        "SLN mapping is indicated"
                    ],
                    "criterion": "SLN mapping",
                    "requirement_type": "indication",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas",
            "criterions": [
                {
                    "exact_snippets": [
                        "Residual clinically or radiographically evident tumor"
                    ],
                    "criterion": "tumor",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "primary cutaneous and mucosal melanomas"
                    ],
                    "criterion": "melanomas",
                    "requirement_type": "type",
                    "expected_value": [
                        "cutaneous",
                        "mucosal"
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior radiation therapy"
                    ],
                    "criterion": "radiation therapy",
                    "requirement_type": "prior",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Prior",
                        "chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "prior",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Prior",
                        "surgery"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "prior",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "patients requiring flap reconstruction in the head and neck region"
                    ],
                    "criterion": "flap reconstruction",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "head and neck region"
                    ],
                    "criterion": "region",
                    "requirement_type": "location",
                    "expected_value": "head and neck"
                }
            ]
        },
        {
            "line": "* Newly diagnosed patients with previous excisional biopsy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Newly diagnosed"
                    ],
                    "criterion": "diagnosis",
                    "requirement_type": "recency",
                    "expected_value": "new"
                },
                {
                    "exact_snippets": [
                        "previous excisional biopsy"
                    ],
                    "criterion": "excisional biopsy",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation",
            "criterions": [
                {
                    "exact_snippets": [
                        "normal baseline cardiac function"
                    ],
                    "criterion": "cardiac function",
                    "requirement_type": "baseline",
                    "expected_value": "normal"
                }
            ]
        },
        {
            "line": "* At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ANC>1000/mcl"
                    ],
                    "criterion": "ANC",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">",
                        "value": 1000
                    }
                },
                {
                    "exact_snippets": [
                        "platelets>100,000/mcl"
                    ],
                    "criterion": "platelets",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">",
                        "value": 100000
                    }
                }
            ]
        },
        {
            "line": "* At the discretion of the physician or surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).",
            "criterions": [
                {
                    "exact_snippets": [
                        "bilirubin level of < 2.0 mg/dl"
                    ],
                    "criterion": "bilirubin level",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "absence of a history of Gilbert's disease"
                    ],
                    "criterion": "Gilbert's disease",
                    "requirement_type": "history",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* For melanoma patients, if patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.",
            "criterions": [
                {
                    "exact_snippets": [
                        "melanoma patients"
                    ],
                    "criterion": "melanoma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of malignancy other than melanoma"
                    ],
                    "criterion": "malignancy history",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other skin cancers in the past five years"
                    ],
                    "criterion": "skin cancer history",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* All patients of childbearing and child-creating age must be using an acceptable form of birth control",
            "criterions": [
                {
                    "exact_snippets": [
                        "patients of childbearing and child-creating age"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": "childbearing and child-creating"
                },
                {
                    "exact_snippets": [
                        "must be using an acceptable form of birth control"
                    ],
                    "criterion": "birth control",
                    "requirement_type": "usage",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Women who are pre-menopausal must have a negative serum pregnancy test",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women who are pre-menopausal"
                    ],
                    "criterion": "menopausal status",
                    "requirement_type": "specificity",
                    "expected_value": "pre-menopausal"
                },
                {
                    "exact_snippets": [
                        "must have a negative serum pregnancy test"
                    ],
                    "criterion": "serum pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Known pregnancy or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breast-feeding"
                    ],
                    "criterion": "breast-feeding",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "chronic renal insufficiency"
                    ],
                    "criterion": "renal insufficiency",
                    "requirement_type": "chronicity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "myocardial infarction within the past 6 months"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "unstable angina"
                    ],
                    "criterion": "angina",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "cardiac arrhythmias other than chronic atrial fibrillation"
                    ],
                    "criterion": "cardiac arrhythmias",
                    "requirement_type": "type",
                    "expected_value": "chronic atrial fibrillation"
                },
                {
                    "exact_snippets": [
                        "chronic active or persistent hepatitis"
                    ],
                    "criterion": "hepatitis",
                    "requirement_type": "chronicity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "New York Heart Association Classification III or IV heart disease"
                    ],
                    "criterion": "New York Heart Association Classification heart disease",
                    "requirement_type": "classification",
                    "expected_value": [
                        "III",
                        "IV"
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}