{
"info": {
"nct_id": "NCT03212157",
"official_title": "Establishment of GlucoCEST MRI as a Biomarker in Cancer Translational Study",
"inclusion_criteria": "* Healthy Volunteers:\n\n 1. No previous history of cancer\n 2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease.\n 3. Aged 18 or over with capacity to consent.\n* Patient groups:\n\n 1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)\n 2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease\n 3. Aged 18 or over with capacity to consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* For both groups:\n\n 1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)\n 2. Pregnancy\n 3. Contradiction to MRI magnetic field (pacemaker, metallic implant, severe claustrophobia, etc)\n 4. Allergy to MR contrast agent (Gadolinium)\n 5. Adult with Impaired capacity\n 6. Deranged renal function with eGFR",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Healthy Volunteers:",
"criterions": [
{
"exact_snippets": "Healthy Volunteers",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "health status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "1. No previous history of cancer",
"criterions": [
{
"exact_snippets": "No previous history of cancer",
"criterion": "history of cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease.",
"criterions": [
{
"exact_snippets": "No known renal impairment",
"criterion": "renal impairment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "eGFR within a standard reference value ... history of renal disease",
"criterion": "eGFR",
"requirements": [
{
"requirement_type": "range",
"expected_value": "within a standard reference value"
}
]
}
]
},
{
"line": "3. Aged 18 or over with capacity to consent.",
"criterions": [
{
"exact_snippets": "Aged 18 or over",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "capacity to consent",
"criterion": "capacity to consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)",
"criterions": [
{
"exact_snippets": "Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": [
"head and neck",
"lymphoma",
"glioma"
]
}
]
}
]
},
{
"line": "2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease",
"criterions": [
{
"exact_snippets": "No known renal impairment",
"criterion": "renal impairment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "eGFR within a standard reference value",
"criterion": "eGFR",
"requirements": [
{
"requirement_type": "range",
"expected_value": "within a standard reference value"
}
]
},
{
"exact_snippets": "history of renal disease",
"criterion": "history of renal disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Aged 18 or over with capacity to consent.",
"criterions": [
{
"exact_snippets": "Aged 18 or over",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "capacity to consent",
"criterion": "capacity to 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 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": "1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)",
"criterions": [
{
"exact_snippets": "Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": [
"head and neck",
"lymphoma",
"glioma"
]
}
]
}
]
},
{
"line": "2. Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "3. Contradiction to MRI magnetic field (pacemaker, metallic implant, severe claustrophobia, etc)",
"criterions": [
{
"exact_snippets": "Contradiction to MRI magnetic field (pacemaker, metallic implant, severe claustrophobia, etc)",
"criterion": "MRI magnetic field contradiction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"pacemaker",
"metallic implant",
"severe claustrophobia"
]
}
]
}
]
},
{
"line": "4. Allergy to MR contrast agent (Gadolinium)",
"criterions": [
{
"exact_snippets": "Allergy to MR contrast agent (Gadolinium)",
"criterion": "allergy to MR contrast agent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Adult with Impaired capacity",
"criterions": [
{
"exact_snippets": "Adult",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": "adult"
}
]
},
{
"exact_snippets": "Impaired capacity",
"criterion": "cognitive capacity",
"requirements": [
{
"requirement_type": "impairment",
"expected_value": true
}
]
}
]
},
{
"line": "6. Deranged renal function with eGFR",
"criterions": [
{
"exact_snippets": "Deranged renal function",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "status",
"expected_value": "deranged"
}
]
},
{
"exact_snippets": "eGFR",
"criterion": "eGFR",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* Patient groups:",
"criterions": []
}
],
"failed_exclusion": [
{
"line": "* For both groups:",
"criterions": []
}
],
"failed_miscellaneous": []
}