NCT06935149已完成1 期
Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools
Primo Biotechnology Co., Ltd1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- PSMA positive detection rate is defined as the rate that is detected positive lesion at the same location/region between [18F]FPSMA-1007 PET/CT (60- minute images) and reference standard.
研究概览
简要总结
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion criteria:
- •The participants can voluntarily sign informed consent forms
- •The participants are male/female over 20 years old.
- •The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer
- •The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT.
- •WHO performance status ≦ 2 points
- •The participants can lie on table for two hours during PSMA-PET/CT scanning.
排除标准
- •To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria.
- •The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.
- •The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.
- •The participants have suffered from liver dysfunction such as AST/ALT ratio >2、total bilirubin >1.5 mg/dL within 6 months.
- •The participants suffered stage IV chronic kidney disease (eGFR<30 mL/min/1.73 m2) within 6 months.
- •The participants suffered acute kidney injury within 6 months.
- •The participants suffered trauma or fracture.
- •The participants are allergic to any radiopharmaceutical or imaging agent.
- •The participants are history of claustrophobia or are inability to remain quiet during the examination.
研究组 & 干预措施
PSMA-PET
Experimental
干预措施: 18-PSMA (Drug)
结局指标
主要结局
PSMA positive detection rate is defined as the rate that is detected positive lesion at the same location/region between [18F]FPSMA-1007 PET/CT (60- minute images) and reference standard.
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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