A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete PET imaging
研究概览
简要总结
The aim of this study was to establish and optimize the [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 65 years of age and of either sex.
- •Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
- •Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
- •Willingness and ability to cooperate with all programs of this study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Severe hepatic and renal insufficiency;
- •Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
- •Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- •History of serious surgery in the last month.
- •Those who have participated in other clinical trials during the same period.
研究组 & 干预措施
patients with renal cancer
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose
干预措施: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging (Radiation)
patients with lymphoma
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose
干预措施: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging (Radiation)
结局指标
主要结局
Complete PET imaging
时间窗: 90mins from time of injection
1\. Establishment and optimization of imaging method for \[18F\]RCCB6 or \[68Ga\]Ga-NOTA-RCCB6 PET/CT imaging. 2. Evaluating the sensitivity and specificity of using \[18F\]RCCB6 or \[68Ga\]Ga-NOTA-RCCB6 PET/CT in diagnosing renal cell carcinoma (especially metastatic clear cell renal carcinoma) and lymphoma.
次要结局
未报告次要终点