{
    "info": {
        "nct_id": "NCT03333031",
        "official_title": "A Phase I Study of HS-196, an HSP90 Inhibitor-linked Near Infrared Probe for Detection of Solid Malignancies",
        "inclusion_criteria": "For Dose escalation and recommended dose phases:\n\n* Diagnosis of a solid malignancy, stage I-IV, with planned surgical resection or biopsy.\n\nFor Expansion phase:\n\n* Patients with mammographically detected breast nodules with planned surgical resection or biopsy.\n\nFor All phases:\n\n* ECOG 0 or 1\n* Estimated life expectancy > 3 months\n* Age ≥ 18 years\n* Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5, PTT <1.5X ULN\n* Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal or if liver metastases are present < 5 x upper limit of normal.\n* Female patients must be of non-child-bearing potential or use effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of study drug;\n* Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.\n* Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Serious chronic or acute illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.\n* Medical or psychological impediment to probable compliance with the protocol.\n* Asthma under medical management\n* Uncontrolled high blood pressure\n* Presence of a known active acute or chronic infection including HIV or viral hepatitis (Hepatitis B and C)).\n* Pregnant or nursing women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "For Dose escalation and recommended dose phases:",
            "criterions": [
                {
                    "exact_snippets": "Dose escalation",
                    "criterion": "dose escalation",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "escalation"
                        }
                    ]
                },
                {
                    "exact_snippets": "recommended dose phases",
                    "criterion": "recommended dose",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "recommended"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of a solid malignancy, stage I-IV, with planned surgical resection or biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of a solid malignancy",
                    "criterion": "solid malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I-IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned surgical resection or biopsy",
                    "criterion": "planned surgical intervention",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgical resection",
                                "biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with mammographically detected breast nodules with planned surgical resection or biopsy.",
            "criterions": [
                {
                    "exact_snippets": "mammographically detected breast nodules",
                    "criterion": "breast nodules",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "mammographically"
                        }
                    ]
                },
                {
                    "exact_snippets": "planned surgical resection or biopsy",
                    "criterion": "surgical resection or biopsy",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5, PTT <1.5X ULN",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function, with WBC ≥ 3000/microliter",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "microliter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function, with ... hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function, with ... platelets ≥ 75,000/microliter",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "microliter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT-INR <1.5",
                    "criterion": "PT-INR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PTT <1.5X ULN",
                    "criterion": "PTT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal or if liver metastases are present < 5 x upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal ... serum creatinine < 1.5 mg/dL",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "serum creatinine level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 1.5,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level (Gilbert's syndrome)",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.0,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST ≤ 2.5 x upper limit of normal",
                    "criterion": "ALT and AST levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x upper limit of normal"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if liver metastases are present < 5 x upper limit of normal",
                    "criterion": "ALT and AST levels (with liver metastases)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x upper limit of normal"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients must be of non-child-bearing potential or use effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of study drug;",
            "criterions": [
                {
                    "exact_snippets": "Female patients must be of non-child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-child-bearing"
                        }
                    ]
                },
                {
                    "exact_snippets": "use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to continue the effective contraception method for 30 days after the last dose of study drug",
                    "criterion": "contraception continuation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "30 days after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand and provide signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to understand",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability to provide signed consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.",
            "criterions": [
                {
                    "exact_snippets": "Ability to return to Duke University Medical Center for adequate follow-up",
                    "criterion": "ability to return to Duke University Medical Center",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate follow-up, as required by this protocol",
                    "criterion": "adequate follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Serious chronic or acute illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.",
            "criterions": [
                {
                    "exact_snippets": "Serious chronic or acute illness",
                    "criterion": "illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "chronic",
                                "acute"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment",
                    "criterion": "risk for investigational drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "unwarranted high risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical or psychological impediment to probable compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Medical ... impediment to probable compliance with the protocol.",
                    "criterion": "medical impediment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological impediment to probable compliance with the protocol.",
                    "criterion": "psychological impediment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Asthma under medical management",
            "criterions": [
                {
                    "exact_snippets": "Asthma under medical management",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": "under medical management"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled high blood pressure",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled high blood pressure",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of a known active acute or chronic infection including HIV or viral hepatitis (Hepatitis B and C)).",
            "criterions": [
                {
                    "exact_snippets": "Presence of a known active acute or chronic infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... viral hepatitis (Hepatitis B and C)",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "For Expansion phase:",
            "criterions": []
        },
        {
            "line": "For All phases:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}