Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET
研究概览
简要总结
Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine scan. This technology allows precise and early cancer to be visualized and measured on whole body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the most important prognostic factors in this disease. The objective of this study is to evaluate if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular proliferation and therefore prognosis of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected somatostatin receptor positive tumor such as: neuroendocrine tumor (carcinoid, gastro-entero-pancreatic neuroendocrine tumors, etc); pheochromocytoma; neuroblastoma; medulloblastoma; ectopic Cushing syndrome/non-pituitary ACTH elevation; tumor-induced osteomalacia. Supporting evidence may include MRI, CT, biochemical markers, and/or pathology report.
- •Previous diagnosis of NET with Ki-67 index available or soon to be obtained.
- •ECOG performance status 0 - 3, inclusive.
- •18 years or older and able to understand and provide written informed consent
- •Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug
排除标准
- •Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
- •Patients who exceed the safe weight limit or bore of the PET/CT bed
- •Patients who are claustrophobic or pregnant
研究组 & 干预措施
68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT scan performed on Neuro-endocrine tumor patients
干预措施: 68Ga-DOTATATE PET/CT (Drug)
结局指标
主要结局
Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET
时间窗: 2 years
To determine whether there is an inverse correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in patients with neuroendocrine tumors
次要结局
未报告次要终点
研究者
Gad Abikhzer
MD
Jewish General Hospital