{
    "info": {
        "nct_id": "NCT04369560",
        "official_title": "Virtual Histology of the Bladder Wall for Bladder Cancer Staging; a Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging",
        "inclusion_criteria": "1. 18 to 90 years of age\n2. Able to understand and willing to sign a written informed consent document\n3. A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.\n4. Performance status of ECOG 0 or 1\n5. Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol.\n2. Severe claustrophobia that will prevent completion of the MRI study.\n3. Any MRI-non-compatible implanted device, prosthetic or pacemaker.\n4. Known or suspected metastatic disease.\n5. Women with active pregnancy, lactation or plans to conceive\n6. Untreated urinary tract infection\n7. Known urethral stricture disease that would prohibit placement of foley catheter.\n8. Any other conditions considered as unacceptable risk by the treating physician",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. 18 to 90 years of age",
            "criterions": [
                {
                    "exact_snippets": "18 to 90 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Able to understand and willing to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "A papillary tumor identified by cystoscopy",
                    "criterion": "papillary tumor",
                    "requirements": [
                        {
                            "requirement_type": "identification method",
                            "expected_value": "cystoscopy"
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for TURBT",
                    "criterion": "TURBT scheduling",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically proven MIBC",
                    "criterion": "MIBC",
                    "requirements": [
                        {
                            "requirement_type": "proof method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically localized",
                    "criterion": "MIBC",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "clinically localized"
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to surgical resection with curative intent",
                    "criterion": "MIBC",
                    "requirements": [
                        {
                            "requirement_type": "surgical resection",
                            "expected_value": "amenable"
                        },
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Performance status of ECOG 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Performance status of ECOG 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol.",
            "criterions": [
                {
                    "exact_snippets": "Severe hypersensitivity reaction to gadobutrol",
                    "criterion": "hypersensitivity reaction to gadobutrol",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe hypersensitivity reaction to ... ferumoxytol",
                    "criterion": "hypersensitivity reaction to ferumoxytol",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Severe claustrophobia that will prevent completion of the MRI study.",
            "criterions": [
                {
                    "exact_snippets": "Severe claustrophobia that will prevent completion of the MRI study.",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "impact on MRI study",
                            "expected_value": "prevent completion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any MRI-non-compatible implanted device, prosthetic or pacemaker.",
            "criterions": [
                {
                    "exact_snippets": "MRI-non-compatible implanted device",
                    "criterion": "implanted device",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": "MRI-non-compatible"
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI-non-compatible ... prosthetic",
                    "criterion": "prosthetic",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": "MRI-non-compatible"
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI-non-compatible ... pacemaker",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": "MRI-non-compatible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Known or suspected metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Women with active pregnancy, lactation or plans to conceive",
            "criterions": [
                {
                    "exact_snippets": "Women with active pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "plans to conceive",
                    "criterion": "plans to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Untreated urinary tract infection",
            "criterions": [
                {
                    "exact_snippets": "Untreated urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known urethral stricture disease that would prohibit placement of foley catheter.",
            "criterions": [
                {
                    "exact_snippets": "Known urethral stricture disease",
                    "criterion": "urethral stricture disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that would prohibit placement of foley catheter",
                    "criterion": "foley catheter placement",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Any other conditions considered as unacceptable risk by the treating physician",
            "criterions": [
                {
                    "exact_snippets": "Any other conditions considered as unacceptable risk by the treating physician",
                    "criterion": "conditions",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "unacceptable risk by the treating physician"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}