Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
研究概览
简要总结
This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of biopsy proven neuroendocrine tumor including (but not limited to): gastrointestinal NET, pancreatic NET, pulmonary NET, NET unknown primary, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
- •At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with SUVmax > SUV meanliver).
- •Age greater or equal to 40
- •Ability to provide written informed consent prior to participation in the study
排除标准
- •Weight > 225 kg (weight limitation of PET/CT scanner)
- •Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
- •Any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
- •Previous allergic reaction to 18F-DOPA
- •Lack of intravenous access
- •Breastfeeding
- •Less than 40 years old
结局指标
主要结局
Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans
时间窗: Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Participants will be categorized as having concordant disease (all lesions 68Ga-HA-DOTATATE avid) or discordant disease (one or more lesions not 68Ga-HA-DOTATATE avid).
次要结局
- SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans(Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans)
- Assessment of disease progression - 12 months(12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans)
- Assessment of disease progression - 18 months(18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans)