{
"info": {
"nct_id": "NCT05673031",
"official_title": "68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors",
"inclusion_criteria": "1. Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required.\n2. Age greater than or equal to 18 years.\n3. Able and willing to follow instructions and comply with the protocol.\n4. Provide written informed consent prior to participation in the study.\n5. Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
"exclusion_criteria": "1. Nursing or pregnant females.\n2. Age less than 18 years.\n3. Surgery in the area of interest within the preceding 2 months.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be 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": "menstrual period",
"requirements": [
{
"requirement_type": "time since last period",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "days"
}
}
]
},
{
"exact_snippets": "a negative pregnancy test will be required",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "2. Age greater than or equal to 18 years.",
"criterions": [
{
"exact_snippets": "Age greater than or equal to 18 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "3. 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": "4. Provide written informed consent prior to participation in the study.",
"criterions": [
{
"exact_snippets": "Provide written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor",
"criterions": [
{
"exact_snippets": "Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome",
"criterion": "carcinoid syndrome",
"requirements": [
{
"requirement_type": "clinical suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "biochemically suggestive of Neuroendocrine Tumor",
"criterion": "Neuroendocrine Tumor",
"requirements": [
{
"requirement_type": "biochemical suggestion",
"expected_value": true
}
]
},
{
"exact_snippets": "Biopsy proven Neuroendocrine Tumor",
"criterion": "Neuroendocrine Tumor",
"requirements": [
{
"requirement_type": "biopsy proven",
"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 100 Years",
"criterions": [
{
"exact_snippets": "maximum age of 100 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Nursing or pregnant females.",
"criterions": [
{
"exact_snippets": "Nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pregnant females",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "2. Age less than 18 years.",
"criterions": [
{
"exact_snippets": "Age less than 18 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "3. Surgery in the area of interest within the preceding 2 months.",
"criterions": [
{
"exact_snippets": "Surgery in the area of interest within the preceding 2 months.",
"criterion": "surgery in the area of interest",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "months"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}