{
    "info": {
        "nct_id": "NCT05126927",
        "official_title": "A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.",
        "inclusion_criteria": "1. Age 18-70 years (including boundary values);\n2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);\n3. Performance status (ECOG) score 0-1 points (see Appendix 1 for details);\n4. Basal heart rate 60-100 beats/min (including boundary values);\n5. Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);\n6. Patients with confirmed solid tumors;\n7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);\n8. Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);\n9. Patients with immunohistochemical CD8 results within the past month;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.\n2. Those who have extremely poor nutritional status and cannot tolerate the trial\n3. Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)\n4. Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions\n5. Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly\n6. Patients with brain metastases.\n7. Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies\n8. Patients who have not recovered from a serious infection\n9. Patients with drug/alcohol abuse, severe mental disorders\n10. Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes\n11. Those who have participated in any other clinical trial within 3 months prior to screening\n12. Women who are pregnant or breastfeeding.\n13. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 18-70 years (including boundary values);",
            "criterions": [
                {
                    "exact_snippets": "Age 18-70 years (including boundary values)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);",
            "criterions": [
                {
                    "exact_snippets": "Have behavioral ability",
                    "criterion": "behavioral ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily participate in this clinical study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form (ICF)",
                    "criterion": "informed consent form (ICF)",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Performance status (ECOG) score 0-1 points (see Appendix 1 for details);",
            "criterions": [
                {
                    "exact_snippets": "Performance status (ECOG) score 0-1 points",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "points"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "points"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Basal heart rate 60-100 beats/min (including boundary values);",
            "criterions": [
                {
                    "exact_snippets": "Basal heart rate 60-100 beats/min (including boundary values)",
                    "criterion": "basal heart rate",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "beats/min"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "beats/min"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);",
            "criterions": [
                {
                    "exact_snippets": "Blood pressure measurement < hypertension grade 1 level",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "< hypertension grade 1 level"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure < 140",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure < 90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with confirmed solid tumors;",
            "criterions": [
                {
                    "exact_snippets": "Patients with confirmed solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);",
            "criterions": [
                {
                    "exact_snippets": "at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1)",
                    "criterion": "image-measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);",
            "criterions": [
                {
                    "exact_snippets": "Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens",
                    "criterion": "tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "biopsy or surgical treatment capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "acceptable modalities",
                            "expected_value": [
                                "enhanced CT",
                                "enhanced MRI",
                                "18F-FDG PET/CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with immunohistochemical CD8 results within the past month;",
            "criterions": [
                {
                    "exact_snippets": "immunohistochemical CD8 results",
                    "criterion": "immunohistochemical CD8 results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past month",
                    "criterion": "immunohistochemical CD8 results",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past month"
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.",
            "criterions": [
                {
                    "exact_snippets": "unable to follow this clinical trial protocol well enough to make visits",
                    "criterion": "ability to make visits",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to follow this clinical trial protocol well enough to ... undergo relevant examinations",
                    "criterion": "ability to undergo relevant examinations",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to follow this clinical trial protocol well enough to ... treatment",
                    "criterion": "ability to undergo treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Those who have extremely poor nutritional status and cannot tolerate the trial",
            "criterions": [
                {
                    "exact_snippets": "extremely poor nutritional status",
                    "criterion": "nutritional status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "extremely poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot tolerate the trial",
                    "criterion": "trial tolerance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)",
            "criterions": [
                {
                    "exact_snippets": "comorbid major diseases",
                    "criterion": "comorbid major diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancies (except those that have healed by one year or do not require additional treatment)",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "healed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions",
            "criterions": [
                {
                    "exact_snippets": "known severe allergy to SNA006",
                    "criterion": "allergy to SNA006",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known severe allergy to ... similar drugs",
                    "criterion": "allergy to similar drugs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known severe allergy to ... excipients",
                    "criterion": "allergy to excipients",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly",
            "criterions": [
                {
                    "exact_snippets": "undergone previous splenectomy",
                    "criterion": "previous splenectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "splenic disease such as hypersplenism",
                    "criterion": "hypersplenism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "splenic disease such as ... splenomegaly",
                    "criterion": "splenomegaly",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies",
            "criterions": [
                {
                    "exact_snippets": "positive results for any of hepatitis B virus surface antigen",
                    "criterion": "hepatitis B virus surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive results for any of ... hepatitis C virus antibodies",
                    "criterion": "hepatitis C virus antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive results for any of ... syphilis-specific antibodies",
                    "criterion": "syphilis-specific antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "those who cannot be determined to be negative for human immunodeficiency virus antibodies",
                    "criterion": "human immunodeficiency virus antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "indeterminate or positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients who have not recovered from a serious infection",
            "criterions": [
                {
                    "exact_snippets": "not recovered from a serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with drug/alcohol abuse, severe mental disorders",
            "criterions": [
                {
                    "exact_snippets": "Patients with drug/alcohol abuse",
                    "criterion": "drug/alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe mental disorders",
                    "criterion": "severe mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes",
            "criterions": [
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "emotional instability",
                    "criterion": "emotional instability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acute persistent spasticity",
                    "criterion": "acute persistent spasticity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to keep both arms up and lying flat for 15-30 minutes",
                    "criterion": "ability to keep both arms up and lying flat",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 15,
                                        "unit": "minutes"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "minutes"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Those who have participated in any other clinical trial within 3 months prior to screening",
            "criterions": [
                {
                    "exact_snippets": "participated in any other clinical trial within 3 months prior to screening",
                    "criterion": "participation in other clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Women who are pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.",
            "criterions": [
                {
                    "exact_snippets": "in the opinion of the investigator, are not suitable to participate",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator's discretion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}