NCT04367948Unknown不适用
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
详细描述
Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- 否
入选标准
- •ECOG score 0 or 1
- •subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery
- •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;
- •conditions that other researchers considered inappropriate for the study.
结局指标
主要结局
SUV
时间窗: 60 days
Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)
次要结局
- SUVR(60 days)
研究者
Xuejuan Wang,MD
Principal Investigator
Peking University Cancer Hospital & Institute
研究点 (1)
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