Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia
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
- Diagnostic value
研究概览
简要总结
This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia.
详细描述
Tumor-induced osteomalacia (TIO) is a rare paraneoplastic syndrome. The main cure for TIO is surgical removal of the responsible tumor. Somatostatin receptors (SSTR) targeted PET imaging with radiolabeled somatostatin analogs can help locate these tumors. It can detect culprit tumors in TIO patients, even small ones that CT or MRI might miss. 68Ga-DOTATATE is the most commonly used SSTR PET tracer for TIO, recommended as the first-line imaging tool to find the causative tumor.
Compared to 68Ga-based tracers, 18F-labelled radiotracers offer several advantages, including higher cyclotron production, lower positron energy, and longer half-life. These features may improve image quality. Al18F-NOTA-LM3 is an SSTR2 specific antagonist used as a PET tracer. This pilot study is designed to compare Al18F-NOTA-LM3 with 68Ga-DOTATATE in the same group of TIO 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
- 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 TIO 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.
研究组 & 干预措施
Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan
Patients of TIO PET/CT imaging: Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT.
干预措施: Diagnostic Test: Al18F-NOTA-LM3 (Drug)
Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan
Patients of TIO PET/CT imaging: Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT.
干预措施: Diagnostic Test: 68Ga-DOTATATE (Drug)
结局指标
主要结局
Diagnostic value
时间窗: From study completion to 6 months after completion.
Sensitivity and specificity of Al18F-NOTA-LM3 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT
次要结局
- standardized uptake value (SUV) of tumor(From study completion to 6 months after completion.)