{
"info": {
"nct_id": "NCT05880394",
"official_title": "Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer",
"inclusion_criteria": "* Age of at least 18 years at the time of signing the informed consent.\n* Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.\n* For women of childbearing potential (WOCBP):\n\n a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).\n* Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE\n* Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.\n* Unable to perform PET/CT scans according to technical specifications and local guidelines.\n* Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.\n* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.\n* Unable or unwilling to comply with the requirements of the study protocol.\n* Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age of at least 18 years at the time of signing the informed consent.",
"criterions": [
{
"exact_snippets": "Age of at least 18 years",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "years"
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}
}
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},
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{
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{
"exact_snippets": "ER+",
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"requirement": {
"requirement_type": "status",
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}
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{
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}
},
{
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}
},
{
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}
},
{
"exact_snippets": "requiring restaging",
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"expected_value": true
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}
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}
}
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"unit": "hours"
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}
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}
},
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"exact_snippets": "at least 6 weeks before taking study drug",
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"requirement": {
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"operator": ">=",
"value": 6,
"unit": "weeks"
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}
}
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"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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},
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}
}
}
},
{
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},
{
"identified_line": {
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{
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},
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"identified_line": {
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{
"exact_snippets": "Known hypersensitivity to Gallium-68 DOTATATE",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to Copper-64 DOTATATE",
"criterion": "hypersensitivity to Copper-64 DOTATATE",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... octreotate",
"criterion": "hypersensitivity to octreotate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... any of the excipients of Gallium-68 DOTATATE",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... any of the excipients of ... Copper-64 DOTATATE",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Known hypersensitivity to Gallium-68 DOTATATE",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... any of the excipients of Gallium-68 DOTATATE",
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"requirement": {
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}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "hypersensitivity to Copper-64 DOTATATE",
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}
},
{
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}
}
]
},
{
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"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
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{
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}
},
{
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}
},
{
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}
},
{
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}
},
{
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}
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]
},
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},
{
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},
{
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},
{
"identified_line": {
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}
},
{
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}
]
},
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}
},
{
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}
}
]
}
}
],
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}