18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
研究概览
简要总结
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-79;
- •The patient must be able to give informed consent;
- •Patients can finish PET/CT scan without tranquilizers;
- •Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;
- •Lesions can be measured and assessed at the RECIST 1.1 standard;
- •No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-[18F]Fluoroglutamine PET/CT.
排除标准
- •Pregnant or lactating patients;
- •Inability or refusal to have at least one peripheral intravenous line for intravenous access;
- •From assays obtained <2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin>1.5*ULN,AST/ALT >2.5 * ULN, Albumin< 3 g/dl, GGT > 2.5 x ULN if ALP> 2.5 x ULN, Creatinine>1.5*ULN or creatinine clearance <60ml/min；
- •Patients with a history of allergic reaction to this drugs or its analogues；
- •patients with poor compliance;
- •Acute major illness
研究组 & 干预措施
4-[18F]Fluoroglutamine
Patients undergo 18F-FDG PET/CT scan first. Within 7 working days, patients receive 4-[18F]Fluoroglutamine IV and 60 minutes after injection, undergo 4-[18F]Fluoroglutamine PET/CT before the start of therapy.
干预措施: 18F-(2S,4R)4-fluoroglutamine (Radiation)
结局指标
主要结局
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
时间窗: up to three years
Sensitivity, specificity, diagnostic accuracy of 4-\[18F\]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.
次要结局
- The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors(up to three years)
- Incidence of Treatment-Emergent Adverse Events(up to 30 days after the F-Gln imaging)
- ASCT2 expression levels in tissue samples(up to three years)