68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Efficacy - sensitivity
研究概览
简要总结
Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.
This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).
详细描述
A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.
Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.
Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
- •A standard clinical CT or MRI is obtained within 6 months of enrollment
- •Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)
排除标准
- •Weight > 225 kg (weight limit of the PET/CT scanner)
- •Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
- •Any additional 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 DOTATATE or somatostatin analogues
- •Lack of intravenous access
研究组 & 干预措施
68Ga-HA-DOTATATE PET/CT scan
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
干预措施: 68Ga-HA-DOTATATE (Drug)
结局指标
主要结局
Efficacy - sensitivity
时间窗: 1 year post-scan
Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Efficacy - specificity
时间窗: 1 year post-scan
Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
次要结局
- Safety - adverse events - delayed(10 days after tracer injection)
- Safety - adverse events - immediate(Immediately (within 15 minutes) after tracer injection)
- Safety - adverse events - post-scan(Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection)