{
    "info": {
        "nct_id": "NCT01805076",
        "official_title": "Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.\n* Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.\n* Patients must have either:\n\n  * Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR\n  * ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors\n  * HER-2 status will be determined as per the 2013 ASCO CAP guidelines:\n\n    * HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH\n    * HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH\n* No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)\n* No patients with bilateral breast cancer\n* No patients with known deleterious mutations in breast cancer (BRCA) genes\n* No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures\n* No history of chemotherapy for cancer within 6 months prior to registration\n* No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery\n* Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.\n* No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled.\n* Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):\n\n  * No history of untreatable claustrophobia\n  * No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\n  * No history of sickle cell disease\n  * No contraindication to intravenous contrast administration\n  * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\n  * No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a creatinine level obtained within 28 days prior to registration\n  * Weight lower than that allowable by the MRI table\n* No prior MRI of study breast within the 12 months prior to registration\n* Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential\n* ≥ 18 years of age\n* Signed study-specific informed consent prior to registration"
    },
    "inclusion_lines": [
        {
            "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 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": [],
    "miscellaneous_lines": [
        {
            "line": "* Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Female. Men are excluded",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed diagnosis of breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis must be by needle biopsy",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "needle biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients diagnosed by surgical excision are excluded",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "exclusion method",
                            "expected_value": "surgical excision"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR",
            "criterions": [
                {
                    "exact_snippets": "Estrogen receptor (ER) negative",
                    "criterion": "Estrogen receptor (ER) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor (PR) negative (< 10% by immunohistochemistry IHC staining)",
                    "criterion": "Progesterone receptor (PR) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "percentage by immunohistochemistry IHC staining",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 negative breast cancer",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors",
            "criterions": [
                {
                    "exact_snippets": "ER negative",
                    "criterion": "ER status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "PR negative (< 10% by IHC staining)",
                    "criterion": "PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "percentage by IHC staining",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 positive tumors",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER-2 status will be determined as per the 2013 ASCO CAP guidelines:",
            "criterions": [
                {
                    "exact_snippets": "HER-2 status",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "as per the 2013 ASCO CAP guidelines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH",
            "criterions": [
                {
                    "exact_snippets": "HER-2 is considered positive if there is IHC 3+ staining",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC staining",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 is considered positive if there is ... ISH positive using either single probe ISH or dual probe ISH",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "ISH",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH",
            "criterions": [
                {
                    "exact_snippets": "HER-2 is considered negative if there is IHC 0 or 1+ staining",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC staining",
                            "expected_value": [
                                "0",
                                "1+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 is considered negative if there is ... ISH negative using either single probe ISH or dual probe ISH",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "ISH result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)",
            "criterions": [
                {
                    "exact_snippets": "previous ipsilateral invasive breast cancer",
                    "criterion": "ipsilateral invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ (DCIS)",
                    "criterion": "ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with bilateral breast cancer",
            "criterions": [
                {
                    "exact_snippets": "No patients with bilateral breast cancer",
                    "criterion": "bilateral breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with known deleterious mutations in breast cancer (BRCA) genes",
            "criterions": [
                {
                    "exact_snippets": "known deleterious mutations in breast cancer (BRCA) genes",
                    "criterion": "BRCA gene mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures",
            "criterions": [
                {
                    "exact_snippets": "No current history of receiving hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "current history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No current history of receiving ... tamoxifen",
                    "criterion": "tamoxifen",
                    "requirements": [
                        {
                            "requirement_type": "current history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No current history of receiving ... aromatase inhibitors",
                    "criterion": "aromatase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "current history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of chemotherapy for cancer within 6 months prior to registration",
            "criterions": [
                {
                    "exact_snippets": "No history of chemotherapy for cancer within 6 months prior to registration",
                    "criterion": "history of chemotherapy for cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery",
            "criterions": [
                {
                    "exact_snippets": "patients scheduled to receive neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients scheduled to receive ... partial breast irradiation following breast conserving surgery",
                    "criterion": "partial breast irradiation following breast conserving surgery",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.",
            "criterions": [
                {
                    "exact_snippets": "Eligible for BCT based on clinical examination",
                    "criterion": "BCT eligibility based on clinical examination",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible for BCT based on ... mammography",
                    "criterion": "BCT eligibility based on mammography",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible for BCT based on ... ultrasound",
                    "criterion": "BCT eligibility based on ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible for BCT based on ... tomogram",
                    "criterion": "BCT eligibility based on tomogram",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who cannot be appropriately selected for BCT based on these standard imaging studies",
                    "criterion": "BCT eligibility based on standard imaging studies",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for whom additional imaging is recommended to clarify local disease extent, will not be eligible",
                    "criterion": "additional imaging recommendation to clarify local disease extent",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):",
            "criterions": [
                {
                    "exact_snippets": "Suitable to undergo MRI",
                    "criterion": "MRI suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receive the contrast agent gadolinium",
                    "criterion": "gadolinium contrast agent suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of untreatable claustrophobia",
            "criterions": [
                {
                    "exact_snippets": "No history of untreatable claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)",
            "criterions": [
                {
                    "exact_snippets": "No presence of metallic objects or implanted medical devices in body",
                    "criterion": "metallic objects or implanted medical devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac pacemaker",
                    "criterion": "cardiac pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "aneurysm clips",
                    "criterion": "aneurysm clips",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical clips",
                    "criterion": "surgical clips",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prostheses",
                    "criterion": "prostheses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "artificial hearts",
                    "criterion": "artificial hearts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "valves with steel parts",
                    "criterion": "valves with steel parts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metal fragments",
                    "criterion": "metal fragments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "shrapnel",
                    "criterion": "shrapnel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tattoos near the eye",
                    "criterion": "tattoos near the eye",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "steel implants",
                    "criterion": "steel implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of sickle cell disease",
            "criterions": [
                {
                    "exact_snippets": "No history of sickle cell disease",
                    "criterion": "sickle cell disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindication to intravenous contrast administration",
            "criterions": [
                {
                    "exact_snippets": "No contraindication to intravenous contrast administration",
                    "criterion": "intravenous contrast administration",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance",
            "criterions": [
                {
                    "exact_snippets": "No known allergy-like reaction to gadolinium",
                    "criterion": "allergy-like reaction to gadolinium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "moderate or severe allergic reactions to one or more allergens",
                    "criterion": "moderate or severe allergic reactions to allergens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a creatinine level obtained within 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine level obtained within 28 days prior to registration",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Weight lower than that allowable by the MRI table",
            "criterions": [
                {
                    "exact_snippets": "Weight lower than that allowable by the MRI table",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "lower than that allowable by the MRI table"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior MRI of study breast within the 12 months prior to registration",
            "criterions": [
                {
                    "exact_snippets": "No prior MRI of study breast within the 12 months prior to registration",
                    "criterion": "MRI of study breast",
                    "requirements": [
                        {
                            "requirement_type": "time since last MRI",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Non-pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-lactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Perimenopausal patients must be amenorrheic > 12 months",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed study-specific informed consent prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Signed study-specific informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* Patients must have either:",
            "criterions": []
        },
        {
            "line": "* No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled.",
            "criterions": [
                {
                    "exact_snippets": "multicentric or multifocal disease",
                    "criterion": "multicentric or multifocal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "multifocal disease that can be encompassed in a single operative bed",
                    "criterion": "multifocal disease in a single operative bed",
                    "requirements": [
                        {
                            "requirement_type": "encompassment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ]
}