{
    "info": {
        "nct_id": "NCT02610920",
        "official_title": "Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer",
        "inclusion_criteria": "* Female patients at least 21 years old\n* Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy\n* Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:\n* Patients having a mastectomy\n* Patients with palpable DCIS\n* Patients undergoing breast conservation with large (>5cm) area of DCIS\n* Patients with signed consent to participate\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Preoperative palpable axillary lymphadenopathy\n* Preoperative ultrasound demonstrating suspicious adenopathy\n* Previous axillary dissection or previous lymph node biopsy\n* Patients with Invasive Lobular Carcinoma\n* Patients who are pregnant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female patients at least 21 years old",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 21 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy",
            "criterions": [
                {
                    "exact_snippets": "invasive ductal carcinoma",
                    "criterion": "invasive ductal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "staged T1 or T2",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "estrogen receptor and progesterone receptor positive (ER+/PR+)",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ER+/PR+"
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for sentinel lymph node biopsy",
                    "criterion": "sentinel lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:",
            "criterions": [
                {
                    "exact_snippets": "Patients with Ductal Carcinoma In Situ (DCIS)",
                    "criterion": "Ductal Carcinoma In Situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(high or low grade)",
                    "criterion": "DCIS grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "high",
                                "low"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for sentinel lymph node biopsy",
                    "criterion": "sentinel lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients having a mastectomy",
            "criterions": [
                {
                    "exact_snippets": "Patients having a mastectomy",
                    "criterion": "mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with palpable DCIS",
            "criterions": [
                {
                    "exact_snippets": "palpable DCIS",
                    "criterion": "DCIS",
                    "requirements": [
                        {
                            "requirement_type": "palpability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients undergoing breast conservation with large (>5cm) area of DCIS",
            "criterions": [
                {
                    "exact_snippets": "breast conservation",
                    "criterion": "breast conservation",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "large (>5cm) area of DCIS",
                    "criterion": "area of DCIS",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with signed consent to participate",
            "criterions": [
                {
                    "exact_snippets": "signed consent to participate",
                    "criterion": "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Preoperative palpable axillary lymphadenopathy",
            "criterions": [
                {
                    "exact_snippets": "palpable axillary lymphadenopathy",
                    "criterion": "axillary lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "palpability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Preoperative ultrasound demonstrating suspicious adenopathy",
            "criterions": [
                {
                    "exact_snippets": "Preoperative ultrasound demonstrating suspicious adenopathy",
                    "criterion": "adenopathy",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "preoperative ultrasound"
                        },
                        {
                            "requirement_type": "characteristic",
                            "expected_value": "suspicious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous axillary dissection or previous lymph node biopsy",
            "criterions": [
                {
                    "exact_snippets": "Previous axillary dissection",
                    "criterion": "axillary dissection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous lymph node biopsy",
                    "criterion": "lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Invasive Lobular Carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Invasive Lobular Carcinoma",
                    "criterion": "Invasive Lobular Carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}