{
    "info": {
        "nct_id": "NCT04776980",
        "official_title": "Multimodality MRI for Quantification of Tumor-associated Macrophages and Prediction of Somatic Mutation Detectability in Cell-free DNA in Adult Patients With Glioblastoma",
        "inclusion_criteria": "1. Participants will be ≥ 18 years of age\n2. Patients with new diagnosis of high grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection\n3. Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.\n4. Karnofsky performance status ≥ 60\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; pregnancy status will be confirmed verbally prior to participating in any study procedures.\n3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study\n4. Contraindications to MRI or use of ferumoxytol or gadolinium contrast",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Participants will be ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Participants will be ≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with new diagnosis of high grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection",
            "criterions": [
                {
                    "exact_snippets": "new diagnosis of high grade glioma based on MRI",
                    "criterion": "high grade glioma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "considered surgical candidates determined by neurosurgeons",
                    "criterion": "surgical candidacy",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "neurosurgeons"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent glioblastoma",
                    "criterion": "recurrent glioblastoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "initial diagnosis of glioblastoma (histologic or molecular proof)",
                    "criterion": "initial glioblastoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "proof",
                            "expected_value": [
                                "histologic",
                                "molecular"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "recommended for clinically surgical resection",
                    "criterion": "surgical resection recommendation",
                    "requirements": [
                        {
                            "requirement_type": "recommendation",
                            "expected_value": "clinically surgical resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Karnofsky performance status ≥ 60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status ≥ 60",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician",
            "criterions": [
                {
                    "exact_snippets": "Inability to tolerate imaging procedures",
                    "criterion": "tolerance to imaging procedures",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; pregnancy status will be confirmed verbally prior to participating in any study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding at the time of screening",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study",
            "criterions": [
                {
                    "exact_snippets": "Any current medical condition, illness, or disorder ... considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study",
                    "criterion": "current medical condition, illness, or disorder",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "could compromise participant safety or successful participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Contraindications to MRI or use of ferumoxytol or gadolinium contrast",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to MRI",
                    "criterion": "MRI",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindications to ... use of ferumoxytol",
                    "criterion": "ferumoxytol",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindications to ... use of ... gadolinium contrast",
                    "criterion": "gadolinium contrast",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}