{
    "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": [
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                "line": "1. 18 to 90 years of age",
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                                        "value": 18,
                                        "unit": "years"
                                    },
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                                        "unit": "years"
                                    }
                                ]
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        },
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                "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.",
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                            "requirement_type": "proof method",
                            "expected_value": "histologically proven"
                        }
                    },
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                            "expected_value": "clinically localized"
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                    },
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                            },
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                                "criterion": "MIBC",
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        },
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                "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.",
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                        "criterion": "creatinine clearance",
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                                "unit": "mL/min/1.73 m2"
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                                "exact_snippets": "Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN)",
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                                "requirement": {
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                                        "unit": "x ULN"
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                                "criterion": "creatinine clearance",
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                                "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 level",
                                "requirement": {
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                                    }
                                }
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        },
        {
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                "line": "Healthy volunteers allowed",
                "criterions": [
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                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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        },
        {
            "identified_line": {
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                    {
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        },
        {
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                    }
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                    }
                ]
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        },
        {
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                "line": "3. Any MRI-non-compatible implanted device, prosthetic or pacemaker.",
                "criterions": [
                    {
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                        "criterion": "implanted device",
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                            "requirement_type": "compatibility",
                            "expected_value": "MRI-non-compatible"
                        }
                    },
                    {
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                        }
                    },
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                            "expected_value": "MRI-non-compatible"
                        }
                    }
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    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. Performance status of ECOG 0 or 1",
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        {
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                    },
                    {
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                    },
                    {
                        "exact_snippets": "plans to conceive",
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}