Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for Tumors Likely to Express High Levels of CAIX
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants must meet the following criteria:
- •Written and voluntarily given Informed Consent.
- •Male or female ≥18 years of age at time of consent.
- •Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- •Participants with histologically confirmed or suspected tumors of the following types, but not limited to:
- •Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.
排除标准
- •Participants will be excluded from participation in the study if one or more of the following criteria are met:
- •Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
- •Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
- •Be a female who is pregnant or breastfeeding.
研究组 & 干预措施
18F-T2 PET/CT
Participants with tumors likely to express high levels of CAIX will receive an intravenous injection of 18F-T2 followed by PET/CT imaging. The participants will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.
干预措施: 18F-T2 PET/CT (Diagnostic Test)
结局指标
主要结局
The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors
时间窗: From study completion to 1 month after completion
The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard.
Safety (AEs and SAEs)
时间窗: 24 hours after the injection of 18F-T2
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
Incidence of Adverse Events [Safety and Tolerability]
时间窗: 24 hours after the injection of 18F-T2
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
次要结局
- Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT(From study completion to 1 month after completion)
- Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT(From study completion to 1 month after completion)
- Correlation between T2 Uptake and CAIX Pathological Expression(From study completion to 1 month after completion)
- Dosimetry of 18F-T2(From study completion to 1 month after completion)
研究者
Meng LIU
Chief Physician
Peking University First Hospital