{
"info": {
"nct_id": "NCT00123773",
"official_title": "A Phase II Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence",
"inclusion_criteria": "* Male or female. (If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)\n* Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular carcinoma (seminomatous and non-seminomatous germ cell tumours), endometrial carcinoma, renal cell carcinoma, pancreatic adenocarcinoma, malignant mesothelioma, gastric carcinoma and cholangiocarcinoma.\n* Age equal to or greater than 15 years\n* Able and willing to follow instructions and comply with the protocol\n* Provide written informed consent prior to participation in this study\n* Karnofsky Performance Scale score 60-100\nHealthy volunteers allowed\nMust have minimum age of 15 Years",
"exclusion_criteria": "* Nursing or pregnant females\n* Having had surgery or radiotherapy within 10 days of the planned imaging study\n* Presence of a severe infection\n* Age less than 15 years\n* Blood glucose greater than 10mmol/L",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male or female. (If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)",
"criterions": [
{
"exact_snippets": "Male or female.",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "female of child bearing potential",
"criterion": "child bearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "outside of the window of 10 days since the last menstrual period",
"criterion": "time since last menstrual period",
"requirements": [
{
"requirement_type": "time since last menstrual period",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "days"
}
}
]
},
{
"exact_snippets": "a negative serum or urine pregnancy test is required",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular carcinoma (seminomatous and non-seminomatous germ cell tumours), endometrial carcinoma, renal cell carcinoma, pancreatic adenocarcinoma, malignant mesothelioma, gastric carcinoma and cholangiocarcinoma.",
"criterions": [
{
"exact_snippets": "Known or suspected primary or metastatic tumours of myeloma",
"criterion": "myeloma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... sarcoma",
"criterion": "sarcoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... testicular carcinoma (seminomatous and non-seminomatous germ cell tumours)",
"criterion": "testicular carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... renal cell carcinoma",
"criterion": "renal cell carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... malignant mesothelioma",
"criterion": "malignant mesothelioma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... gastric carcinoma",
"criterion": "gastric carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Known or suspected primary or metastatic tumours of ... cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Age equal to or greater than 15 years",
"criterions": [
{
"exact_snippets": "Age equal to or greater than 15 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 15,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Able and willing to follow instructions and comply with the protocol",
"criterions": [
{
"exact_snippets": "Able and willing to follow instructions",
"criterion": "ability and willingness to follow instructions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "comply with the protocol",
"criterion": "compliance with the protocol",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Provide written informed consent prior to participation in this study",
"criterions": [
{
"exact_snippets": "written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Karnofsky Performance Scale score 60-100",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Scale score 60-100",
"criterion": "Karnofsky Performance Scale score",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "N/A"
},
{
"operator": "<=",
"value": 100,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"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 15 Years",
"criterions": [
{
"exact_snippets": "minimum age of 15 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Nursing or pregnant females",
"criterions": [
{
"exact_snippets": "Nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "nursing"
}
]
},
{
"exact_snippets": "pregnant females",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "pregnant"
}
]
}
]
},
{
"line": "* Having had surgery or radiotherapy within 10 days of the planned imaging study",
"criterions": [
{
"exact_snippets": "Having had surgery ... within 10 days of the planned imaging study",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "days"
}
}
]
},
{
"exact_snippets": "Having had ... radiotherapy within 10 days of the planned imaging study",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Presence of a severe infection",
"criterions": [
{
"exact_snippets": "Presence of a severe infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Age less than 15 years",
"criterions": [
{
"exact_snippets": "Age less than 15 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 15,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Blood glucose greater than 10mmol/L",
"criterions": [
{
"exact_snippets": "Blood glucose greater than 10mmol/L",
"criterion": "blood glucose",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mmol/L"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}