A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection in Patients With Pheochromocytoma and Paraganglioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tumor Detection Rate
研究概览
简要总结
The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-LM3 PET/CT and compare it with 68Ga-DOTATATE PET/CT in patients with pheochromocytoma/paraganglioma (PPGL).
详细描述
68Ga-based somatostatin receptor (SSTR) PET/CT has emerged as the cornerstone for staging and monitoring metastatic pheochromocytoma and paraganglioma (mPPGL), including its integral theranostic role in selecting patients for peptide receptor radionuclide therapy (PRRT). Compared to conventional 68Ga-DOTA-SSA analogs, 18F-labeled SSTR antagonists offer advantages including higher yield, superior image resolution, and longer half-life, potentially facilitating clinical workflow. Al18F-NOTA-LM3 is an SSTR2-specific antagonist developed as a PET tracer, with preliminary data supporting its safety, favorable biodistribution, and effective lesion targeting. This study aims to evaluate the diagnostic efficacy of Al18F-NOTA-LM3 PET/CT compared to 68Ga-DOTATATE PET/CT in a cohort of patients with PPGL.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years.
- •Suspected or confirmed PPGL patients.
排除标准
- •Combined with other types of tumors.
- •Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR<30ml/min).
- •Pregnant or breast-feeding women.
- •Inability to perform PET/CT scans.
结局指标
主要结局
Tumor Detection Rate
时间窗: From study completion to 6 months after completion.
Compare the number of tumor detected by Al18F-NOTA-LM3 PET/CT and 68Ga-DOTATATE PET/CT
次要结局
- Standardized Uptake Value (SUV) of Tumor(From study completion to 6 months after completion.)