{
    "info": {
        "nct_id": "NCT06355427",
        "official_title": "The Effect of [18F] F-FAPI PET-CT on Management in Patients with Potentially Resectable Biliary Tract Cancers: Prospective Multicenter Study and Cost-effectivity Analysis",
        "inclusion_criteria": "* Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)\n* Tumor is regarded as resectable based on preoperative CT and MRI\n* Patient is 18 years or older and is able to give informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous abdominal surgery or chemotherapy\n* Patient had FDG PET-CT in addition to preoperative CT and MRI\n* Contra-indication for performing PET-CT\n* Indication for FDG PET-CT\n* Pregnancy or lactation, for the latter, temporary discontinuation may be considered.\n* Known allergic reaction to therapeutic radiopharmaceuticals\n* Inability to lie still on the back for the duration of PET-CT\n* Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.\n* Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)",
            "criterions": [
                {
                    "exact_snippets": "scheduled for explorative laparoscopy or laparotomy",
                    "criterion": "scheduled procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "explorative laparoscopy",
                                "laparotomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)",
                    "criterion": "suspicion of proximal cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "subtypes",
                            "expected_value": [
                                "perihilar",
                                "intrahepatic",
                                "gall bladder"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor is regarded as resectable based on preoperative CT and MRI",
            "criterions": [
                {
                    "exact_snippets": "Tumor is regarded as resectable based on preoperative CT and MRI",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": [
                                "preoperative CT",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is 18 years or older and is able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient is 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Previous abdominal surgery or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous abdominal surgery",
                    "criterion": "abdominal surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient had FDG PET-CT in addition to preoperative CT and MRI",
            "criterions": [
                {
                    "exact_snippets": "Patient had FDG PET-CT",
                    "criterion": "FDG PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative CT",
                    "criterion": "preoperative CT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative ... MRI",
                    "criterion": "preoperative MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contra-indication for performing PET-CT",
            "criterions": [
                {
                    "exact_snippets": "Contra-indication for performing PET-CT",
                    "criterion": "PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "contra-indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Indication for FDG PET-CT",
            "criterions": [
                {
                    "exact_snippets": "Indication for FDG PET-CT",
                    "criterion": "FDG PET-CT indication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation, for the latter, temporary discontinuation may be considered.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergic reaction to therapeutic radiopharmaceuticals",
            "criterions": [
                {
                    "exact_snippets": "Known allergic reaction to therapeutic radiopharmaceuticals",
                    "criterion": "allergic reaction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to lie still on the back for the duration of PET-CT",
            "criterions": [
                {
                    "exact_snippets": "Inability to lie still on the back for the duration of PET-CT",
                    "criterion": "ability to lie still on the back",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)",
            "criterions": [
                {
                    "exact_snippets": "Any (other) condition, disease, metabolic dysfunction",
                    "criterion": "condition, disease, metabolic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect the interpretation of the results or contribute to study burden"
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination finding",
                    "criterion": "physical examination finding",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect the interpretation of the results or contribute to study burden"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical laboratory finding",
                    "criterion": "clinical laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect the interpretation of the results or contribute to study burden"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-suppressible claustrophobia",
                    "criterion": "non-suppressible claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect the interpretation of the results or contribute to study burden"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "eGFR (MDRD)",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "ml/min/1,73 m2"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}