Comparison of Positron Nuclide Labeled DOTA-FAPI PET and FDG PET Study in Colocrectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- finial clinical staging（TNM）
研究概览
简要总结
To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers
详细描述
Participants first undergo an 18F-FDG PET/CT, followed by 68Ga-FAPI04 PET/CT in groups. The purpose of the study is to explore the possibility of superiority of FAPI in diagnosis of colorectal cancer (TNM staging) by the comparison of the two tracers uptake (the maximum of standardized uptake value, SUVmax). Histopathology and conventional imaging follow-up are served as the reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG score 0-2
- •patients with newly diagnosed or previously treated colorectal cancers
- •patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy
- •patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging)
- •expected survival ≥12 weeks
- •blood routine, liver and kidney function meet the following criteria : blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less; Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
- •at least one measurable target lesion according to RECIST1.1
- •women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period
- •able to understand and sign the informed consent voluntarily, with good compliance.
排除标准
- •severe abnormalities of liver and kidney function;
- •women preparing for pregnancy, pregnancy and lactation;
- •cannot lie supine for half an hour;
- •refuse to join the clinical researcher;
- •suffering from claustrophobia or other mental illness;
结局指标
主要结局
finial clinical staging（TNM）
时间窗: 60-120days
To explore the effect of FAPI PET/CT on staging of Colorectal cancer by comparing with FDG PET/CT
次要结局
- SUVmax(60-120days)
研究者
Xuejuan Wang,MD
Deputy Director of Nuclear Medicine
Peking University Cancer Hospital & Institute