{
"info": {
"nct_id": "NCT03689231",
"official_title": "Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs).",
"inclusion_criteria": "* Well differentiated intestinal neuroendocrine tumor with at least one liver metastasis\n* The liver metastasis must be visible and measurable on CT scans or MRI\n* Patients monitored without invasive liver treatment : surgery, RF ablation / Trans-arterial chemoembolization\n* Patients monitored without systemic treatment such as: Chemotherapy, Everolimus, Sunitinib (Somatostatin analogues allowed)\n* Surgery of the primary tumor allowed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Other type of NETs\n* Absence of liver metastases\n* Liver metastases not visible on CT scans/MRI, poorly limited lesions and small target lesions ( less than 10mm) that are difficult to measure\n* Lesions visible only on diffusion-weighted imaging -MRI acquisitions, thus presenting poorly limited contours\n* Invasive liver treatment : surgery, Radio frequency / Trans-arterial chemoembolization\n* Systemic treatments: Chemotherapy / Everolimus / Sunitinib\n* Insufficient follow-up data",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Well differentiated intestinal neuroendocrine tumor with at least one liver metastasis",
"criterions": [
{
"exact_snippets": "Well differentiated intestinal neuroendocrine tumor",
"criterion": "intestinal neuroendocrine tumor",
"requirement": {
"requirement_type": "differentiation",
"expected_value": "well differentiated"
}
},
{
"exact_snippets": "at least one liver metastasis",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "metastasis"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Well differentiated intestinal neuroendocrine tumor",
"criterion": "intestinal neuroendocrine tumor",
"requirement": {
"requirement_type": "differentiation",
"expected_value": "well differentiated"
}
},
{
"exact_snippets": "at least one liver metastasis",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "metastasis"
}
}
}
]
}
},
{
"identified_line": {
"line": "* The liver metastasis must be visible and measurable on CT scans or MRI",
"criterions": [
{
"exact_snippets": "liver metastasis must be visible",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "visibility",
"expected_value": true
}
},
{
"exact_snippets": "liver metastasis ... measurable on CT scans or MRI",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "liver metastasis must be visible",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "visibility",
"expected_value": true
}
},
{
"exact_snippets": "liver metastasis ... measurable on CT scans or MRI",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "liver metastasis must be visible",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "visibility",
"expected_value": true
}
},
{
"exact_snippets": "liver metastasis ... measurable on CT scans or MRI",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients monitored without invasive liver treatment : surgery, RF ablation / Trans-arterial chemoembolization",
"criterions": [
{
"exact_snippets": "Patients monitored without invasive liver treatment : surgery",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"surgery"
]
}
},
{
"exact_snippets": "Patients monitored without invasive liver treatment : ... RF ablation",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"RF ablation"
]
}
},
{
"exact_snippets": "Patients monitored without invasive liver treatment : ... Trans-arterial chemoembolization",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"Trans-arterial chemoembolization"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients monitored without invasive liver treatment : surgery",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"surgery"
]
}
},
{
"exact_snippets": "Patients monitored without invasive liver treatment : ... RF ablation",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"RF ablation"
]
}
}
]
},
{
"exact_snippets": "Patients monitored without invasive liver treatment : ... Trans-arterial chemoembolization",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "absence",
"expected_value": [
"Trans-arterial chemoembolization"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patients monitored without systemic treatment such as: Chemotherapy, Everolimus, Sunitinib (Somatostatin analogues allowed)",
"criterions": [
{
"exact_snippets": "Patients monitored without systemic treatment such as: Chemotherapy",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients monitored without systemic treatment such as: ... Everolimus",
"criterion": "Everolimus treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients monitored without systemic treatment such as: ... Sunitinib",
"criterion": "Sunitinib treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "(Somatostatin analogues allowed)",
"criterion": "Somatostatin analogues",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients monitored without systemic treatment such as: Chemotherapy",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients monitored without systemic treatment such as: ... Everolimus",
"criterion": "Everolimus treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Patients monitored without systemic treatment such as: ... Sunitinib",
"criterion": "Sunitinib treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "(Somatostatin analogues allowed)",
"criterion": "Somatostatin analogues",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Surgery of the primary tumor allowed",
"criterions": [
{
"exact_snippets": "Surgery of the primary tumor allowed",
"criterion": "surgery of the primary tumor",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgery of the primary tumor allowed",
"criterion": "surgery of the primary tumor",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Other type of NETs",
"criterions": [
{
"exact_snippets": "Other type of NETs",
"criterion": "type of NETs",
"requirement": {
"requirement_type": "type",
"expected_value": "other"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Other type of NETs",
"criterion": "type of NETs",
"requirement": {
"requirement_type": "type",
"expected_value": "other"
}
}
}
},
{
"identified_line": {
"line": "* Absence of liver metastases",
"criterions": [
{
"exact_snippets": "Absence of liver metastases",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Absence of liver metastases",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Liver metastases not visible on CT scans/MRI, poorly limited lesions and small target lesions ( less than 10mm) that are difficult to measure",
"criterions": [
{
"exact_snippets": "Liver metastases not visible on CT scans/MRI",
"criterion": "liver metastases visibility",
"requirement": {
"requirement_type": "visibility",
"expected_value": false
}
},
{
"exact_snippets": "poorly limited lesions",
"criterion": "lesion limitation",
"requirement": {
"requirement_type": "limitation",
"expected_value": "poorly limited"
}
},
{
"exact_snippets": "small target lesions ( less than 10mm)",
"criterion": "target lesion size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": "small target lesions ... that are difficult to measure",
"criterion": "target lesion measurability",
"requirement": {
"requirement_type": "measurability",
"expected_value": "difficult to measure"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Liver metastases not visible on CT scans/MRI",
"criterion": "liver metastases visibility",
"requirement": {
"requirement_type": "visibility",
"expected_value": false
}
},
{
"exact_snippets": "poorly limited lesions",
"criterion": "lesion limitation",
"requirement": {
"requirement_type": "limitation",
"expected_value": "poorly limited"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "small target lesions ( less than 10mm)",
"criterion": "target lesion size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": "small target lesions ... that are difficult to measure",
"criterion": "target lesion measurability",
"requirement": {
"requirement_type": "measurability",
"expected_value": "difficult to measure"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Lesions visible only on diffusion-weighted imaging -MRI acquisitions, thus presenting poorly limited contours",
"criterions": [
{
"exact_snippets": "Lesions visible only on diffusion-weighted imaging -MRI acquisitions",
"criterion": "lesions",
"requirement": {
"requirement_type": "visibility",
"expected_value": "only on diffusion-weighted imaging -MRI acquisitions"
}
},
{
"exact_snippets": "presenting poorly limited contours",
"criterion": "lesion contours",
"requirement": {
"requirement_type": "definition",
"expected_value": "poorly limited"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lesions visible only on diffusion-weighted imaging -MRI acquisitions",
"criterion": "lesions",
"requirement": {
"requirement_type": "visibility",
"expected_value": "only on diffusion-weighted imaging -MRI acquisitions"
}
},
{
"exact_snippets": "presenting poorly limited contours",
"criterion": "lesion contours",
"requirement": {
"requirement_type": "definition",
"expected_value": "poorly limited"
}
}
]
}
},
{
"identified_line": {
"line": "* Invasive liver treatment : surgery, Radio frequency / Trans-arterial chemoembolization",
"criterions": [
{
"exact_snippets": "Invasive liver treatment : surgery",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "surgery"
}
},
{
"exact_snippets": "Invasive liver treatment : ... Radio frequency",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Radio frequency"
}
},
{
"exact_snippets": "Invasive liver treatment : ... Trans-arterial chemoembolization",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Trans-arterial chemoembolization"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Invasive liver treatment : surgery",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "surgery"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Invasive liver treatment : ... Radio frequency",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Radio frequency"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Invasive liver treatment : ... Trans-arterial chemoembolization",
"criterion": "invasive liver treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Trans-arterial chemoembolization"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Systemic treatments: Chemotherapy / Everolimus / Sunitinib",
"criterions": [
{
"exact_snippets": "Systemic treatments: Chemotherapy",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Chemotherapy"
}
},
{
"exact_snippets": "Systemic treatments: ... Everolimus",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Everolimus"
}
},
{
"exact_snippets": "Systemic treatments: ... Sunitinib",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Sunitinib"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Systemic treatments: Chemotherapy",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Chemotherapy"
}
},
{
"exact_snippets": "Systemic treatments: ... Everolimus",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Everolimus"
}
},
{
"exact_snippets": "Systemic treatments: ... Sunitinib",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "Sunitinib"
}
}
]
}
},
{
"identified_line": {
"line": "* Insufficient follow-up data",
"criterions": [
{
"exact_snippets": "Insufficient follow-up data",
"criterion": "follow-up data",
"requirement": {
"requirement_type": "sufficiency",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Insufficient follow-up data",
"criterion": "follow-up data",
"requirement": {
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"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}