{
    "info": {
        "nct_id": "NCT06525831",
        "official_title": "Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value",
        "inclusion_criteria": "* Adult patients (≥ 18 years of age)\n* Scheduled for surgical management with nephrectomy for kidney tumor in the urology department of Bordeaux University Hospital\n* CT scan available or scheduled for surgery\n* Consent expressed for integration of the UroCCR database\n* Expressed consent for participation in the Rein 3D Print Mechanics study\n* Patients affiliated or benefiting from social security system\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* - Pregnant or breast-feeding women\n* Contraindication to MRI (Magnetic Resonance Imaging)\n* Contraindication to injection of gadoline contrast agents\n* Biopsy prior to MRI, CT and ultrasound scans (risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma).\n* Presence of thoracolumbar arthrodesis material\n* Obese patient (body mass index ≥ 30 kg/m²)\n* Cystic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm\n* Necrotic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm\n* Ascites\n* Person under legal protection\n* Difficulty understanding and expressing in French",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult patients (≥ 18 years of age)",
            "criterions": [
                {
                    "exact_snippets": "Adult patients (≥ 18 years of age)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled for surgical management with nephrectomy for kidney tumor in the urology department of Bordeaux University Hospital",
            "criterions": [
                {
                    "exact_snippets": "Scheduled for surgical management with nephrectomy",
                    "criterion": "surgical management",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "nephrectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney tumor",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "urology department of Bordeaux University Hospital",
                    "criterion": "location",
                    "requirements": [
                        {
                            "requirement_type": "department",
                            "expected_value": "urology"
                        },
                        {
                            "requirement_type": "hospital",
                            "expected_value": "Bordeaux University Hospital"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CT scan available or scheduled for surgery",
            "criterions": [
                {
                    "exact_snippets": "CT scan available",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Consent expressed for integration of the UroCCR database",
            "criterions": [
                {
                    "exact_snippets": "Consent expressed for integration of the UroCCR database",
                    "criterion": "consent for UroCCR database integration",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expressed consent for participation in the Rein 3D Print Mechanics study",
            "criterions": [
                {
                    "exact_snippets": "Expressed consent for participation",
                    "criterion": "consent for participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients affiliated or benefiting from social security system",
            "criterions": [
                {
                    "exact_snippets": "affiliated or benefiting from social security system",
                    "criterion": "social security system affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "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 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": "* - Pregnant or breast-feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to MRI (Magnetic Resonance Imaging)",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to MRI (Magnetic Resonance Imaging)",
                    "criterion": "MRI contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to injection of gadoline contrast agents",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to injection of gadoline contrast agents",
                    "criterion": "gadoline contrast agent injection",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy prior to MRI, CT and ultrasound scans (risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma).",
            "criterions": [
                {
                    "exact_snippets": "Biopsy prior to MRI, CT and ultrasound scans",
                    "criterion": "biopsy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to MRI, CT and ultrasound scans"
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma",
                    "criterion": "risk of artifactual alteration",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "iatrogenic hemorrhagic changes"
                        }
                    ]
                },
                {
                    "exact_snippets": "biomechanical properties of the renal tumor and parenchyma",
                    "criterion": "biomechanical properties",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "renal tumor",
                                "parenchyma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of thoracolumbar arthrodesis material",
            "criterions": [
                {
                    "exact_snippets": "Presence of thoracolumbar arthrodesis material",
                    "criterion": "thoracolumbar arthrodesis material",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Obese patient (body mass index ≥ 30 kg/m²)",
            "criterions": [
                {
                    "exact_snippets": "Obese patient (body mass index ≥ 30 kg/m²)",
                    "criterion": "body mass index",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "kg/m²"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cystic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm",
            "criterions": [
                {
                    "exact_snippets": "Cystic renal tumors with solid component",
                    "criterion": "cystic renal tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "solid component (corresponding to either parietal thickening or tumor bud) < 2 cm",
                    "criterion": "solid component size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Necrotic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm",
            "criterions": [
                {
                    "exact_snippets": "Necrotic renal tumors",
                    "criterion": "necrotic renal tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "solid component ... < 2 cm",
                    "criterion": "solid component size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ascites",
            "criterions": [
                {
                    "exact_snippets": "Ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Person under legal protection",
            "criterions": [
                {
                    "exact_snippets": "Person under legal protection",
                    "criterion": "legal protection status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under legal protection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Difficulty understanding and expressing in French",
            "criterions": [
                {
                    "exact_snippets": "Difficulty understanding and expressing in French",
                    "criterion": "French language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "difficulty understanding and expressing"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}