{
    "info": {
        "nct_id": "NCT04411966",
        "official_title": "Integrating 18F-FDG PET/CT With 18F-FLT PET/CT in Predicting Treatment Response and Prognosis of Metastatic/Recurrent Breast Cancer",
        "inclusion_criteria": "* Participants must have histological evidence of breast cancer of any stage\n* Participants must be diagnosed with metastatic breast cancer\n* Participants should be willing and able to have both PET-CT scans\n* Participants should be eligible for and plan to undergo systemic chemotherapy and should be seen by a oncologist prior to beginning the study\n* Participants should have the ability to understand and the willingness to sign a written informed consent document\n* Participants must sign a study specific consent form prior to registration\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Patients have been diagnosed with other malignancy\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded\n* Pregnant women are excluded from this study\n* Breast feeding women are excluded from this study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have histological evidence of breast cancer of any stage",
            "criterions": [
                {
                    "exact_snippets": "histological evidence of breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer of any stage",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be diagnosed with metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with metastatic breast cancer",
                    "criterion": "metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants should be willing and able to have both PET-CT scans",
            "criterions": [
                {
                    "exact_snippets": "willing and able to have both PET-CT scans",
                    "criterion": "PET-CT scans",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants should be eligible for and plan to undergo systemic chemotherapy and should be seen by a oncologist prior to beginning the study",
            "criterions": [
                {
                    "exact_snippets": "Participants should be eligible for ... systemic chemotherapy",
                    "criterion": "systemic chemotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to undergo systemic chemotherapy",
                    "criterion": "systemic chemotherapy plan",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should be seen by a oncologist prior to beginning the study",
                    "criterion": "oncologist consultation",
                    "requirements": [
                        {
                            "requirement_type": "consultation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants should have the ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must sign a study specific consent form prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Participants must sign a study specific consent form",
                    "criterion": "consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients have been diagnosed with other malignancy",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with other malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "significant inflammation at treatment site",
                    "criterion": "inflammation at treatment site",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "lab values do not meet the criteria above",
                    "criterion": "lab values",
                    "requirements": [
                        {
                            "requirement_type": "compliance with criteria",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women are excluded from this study",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Breast feeding women are excluded from this study",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding women are excluded",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}