NCT06091748已完成3 期
An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
研究概览
简要总结
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide a written informed consent;
- •18~75 years old,male or female；
- •ECOG performance status 0 or 1;
- •Confirmed or suspicion of GEP-NET.
排除标准
- •Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
- •Individuals planning to be pregnant, and lactating women;
- •Individuals with concurrent active infections or with unexplained fever >38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.
研究组 & 干预措施
PET/CT imaging with 68Ga-DOTATOC
Experimental
干预措施: 68Ga-DOTATOC (Drug)
结局指标
主要结局
Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
时间窗: 12 months
The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
时间窗: 12 months
The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
次要结局
- Incidence and severity of AE and SAE(up to 1 year follow-up)
研究者
研究点 (1)
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