{
    "info": {
        "nct_id": "NCT06136065",
        "official_title": "68Ga-FAPI-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation",
        "inclusion_criteria": "1. Patients must have histologically or cytologically solid tumors at any stage, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion;\n2. 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography or other clinical practice morpho-functional imaging scan dubious or inconclusive;\n3. Male or Female, aged>18 years\n4. Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A)\n5. A female participant is eligible to participate if she is not pregnant and not breastfeeding. If female of childbearing potential highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\", (See Appendix D) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.\n6. Participant is willing and able to give informed consent for participation in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 half lives of the study drug.\n2. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fibroblast Activating Protein Inhibitor or other agents used in the study.\n4. Inability to remain still for the entire duration of the exam\n5. Life expectancy < 6 months\n6. Eastern Cooperative Oncology Group (ECOG) performance status > 2\n7. Patient with compromised renal function (Creatinine> 2 mg/ml)\n8. Patient with altered hepatic function (AST and Alanine Aminotransferase > 2.5 respect to upper normal limits)\n9. Pregnancy and lactation\n10. Subject deprived of its freedom by administrative or legal decision or who is under guardianship",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients must have histologically or cytologically solid tumors at any stage, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion;",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy is no feasible for technical reason or risk benefit balance",
                    "criterion": "biopsy feasibility",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "CT or MRI strongly suggest oncological lesion",
                    "criterion": "oncological lesion",
                    "requirements": [
                        {
                            "requirement_type": "imaging evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography or other clinical practice morpho-functional imaging scan dubious or inconclusive;",
            "criterions": [
                {
                    "exact_snippets": "18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography or other clinical practice morpho-functional imaging scan dubious or inconclusive",
                    "criterion": "imaging scan result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": [
                                "dubious",
                                "inconclusive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Male or Female, aged>18 years",
            "criterions": [
                {
                    "exact_snippets": "Male or Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aged>18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A)",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status <2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. A female participant is eligible to participate if she is not pregnant and not breastfeeding. If female of childbearing potential highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\", (See Appendix D) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.",
            "criterions": [
                {
                    "exact_snippets": "female participant is eligible to participate if she is not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "female participant is eligible to participate if she is ... not breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "female of childbearing potential ... highly effective birth control methods ... are mandatory",
                    "criterion": "birth control methods for female of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug",
                    "criterion": "duration of birth control use for female",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "beginning at screening visit and continuing at least 6 months following last treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control",
                    "criterion": "birth control methods for male patient and female partner",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception)",
                    "criterion": "birth control methods for male patient and female partner",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "condom",
                                "another method"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "starting at screening and continuing throughout the study period and for 6 months after final study drug administration",
                    "criterion": "duration of birth control use for male patient and female partner",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "starting at screening and continuing throughout the study period and for 6 months after final study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participant is willing and able to give informed consent for participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant is willing ... to give informed consent",
                    "criterion": "willingness to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant is ... able to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "1. Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 half lives of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "Participation in another clinical trial with any investigational agents within 30 days prior to study entry",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participation in another clinical trial with any investigational agents ... 5 half lives of the study drug",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half lives of the study drug"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent",
            "criterions": [
                {
                    "exact_snippets": "Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "would not allow the participant to understand, or sign the informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on consent",
                            "expected_value": "would not allow the participant to understand, or sign the informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fibroblast Activating Protein Inhibitor or other agents used in the study.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fibroblast Activating Protein Inhibitor",
                    "criterion": "allergic reactions to compounds similar to Fibroblast Activating Protein Inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to ... other agents used in the study",
                    "criterion": "allergic reactions to other agents used in the study",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Inability to remain still for the entire duration of the exam",
            "criterions": [
                {
                    "exact_snippets": "Inability to remain still for the entire duration of the exam",
                    "criterion": "ability to remain still",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy < 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy < 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status > 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status > 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient with compromised renal function (Creatinine> 2 mg/ml)",
            "criterions": [
                {
                    "exact_snippets": "compromised renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "compromised"
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine> 2 mg/ml",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "mg/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient with altered hepatic function (AST and Alanine Aminotransferase > 2.5 respect to upper normal limits)",
            "criterions": [
                {
                    "exact_snippets": "altered hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "altered"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... > 2.5 respect to upper normal limits",
                    "criterion": "AST (Aspartate Aminotransferase)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times upper normal limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine Aminotransferase > 2.5 respect to upper normal limits",
                    "criterion": "Alanine Aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times upper normal limits"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnancy and lactation",
            "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": "10. Subject deprived of its freedom by administrative or legal decision or who is under guardianship",
            "criterions": [
                {
                    "exact_snippets": "Subject deprived of its freedom by administrative or legal decision",
                    "criterion": "freedom status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deprived"
                        }
                    ]
                },
                {
                    "exact_snippets": "under guardianship",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under guardianship"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}