A Prospective, Open-label, Single-center Study of CD70-Specific PET/CT Imaging for Non-invasive Diagnosis of Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Standardized uptake value (SUVmax)
研究概览
简要总结
This is a prospective, open-label, single-center clinical study targeting renal cell carcinoma. Sixty patients with a high clinical suspicion of renal cell carcinoma were included. Qualified subjects will undergo 68Ga-NOTA-RCCB6 PET/CT examination. The aim is to establish the optimal imaging protocol; evaluate the distribution characteristics and correlations of physiological and pathological positive uptake, and using pathological results as the gold standard, assess the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.
详细描述
This research process is divided into screening period, baseline period, safety visit period, and diagnostic efficacy follow-up period.
- Screening period (D-7 to D-1): No more than 7 days
Screening is conducted within 7 days before the administration of 68Ga-NOTA-RCCB6 (D-7 to D-1). Before any study-related procedures, subjects must sign a written informed consent form. After signing the informed consent form, the following screening procedures are performed:
① Review of inclusion/exclusion criteria.
-
Collection of medical history, including but not limited to clinical data of the subjects and relevant auxiliary examination results (routine imaging examinations, tumor markers, biopsy results, etc.), numbering each subject and establishing a medical record.
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Collection of demographic data (including gender, age, etc.). ④ Recording of concomitant medications/adverse events. If any inclusion criteria are not met or any exclusion criteria are met, the screening is considered failed.
- Baseline period (drug/administration period) (D0): 1 day Subjects who meet all inclusion criteria and do not meet any exclusion criteria will receive an injection of 68Ga-NOTA-RCCB6 and undergo a PET/CT scan on D0. The following assessments are performed again before administration, and only after a comprehensive evaluation by the doctor are they eligible for injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The subject or legal guardian/caregiver must voluntarily sign the informed consent form.
- •Ages 18 to 75 years old. Patients with suspected renal cell carcinoma based on conventional imaging studies, and who undergo 68Ga-PSMA PET/CT scanning.
- •Patients with suspicious lymph nodes or distant metastases detected by conventional imaging or 68Ga-PSMA PET/CT.
- •Willing and able to follow the study protocol.
排除标准
- •Patients who have received anti-tumor treatment prior to PET/CT scan. Suffer from severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, respiratory system, immunodeficiency and other serious diseases.
- •Alternative subjects have contraindications to PET/CT scanning. Including but not limited to: those who cannot tolerate repeated intravenous injections; those who may be allergic to the drug and its components (including those with a history of severe allergies or allergic reactions, especially those with allergies to the tested drug); claustrophobia.
- •In the past year, diagnosed with other malignant tumors; alternative subjects have undergone major surgery in the past 3 months; received experimental drug or device treatment with unclear effects or safety within the past month, or have participated in other interventional clinical trials.
- •Pregnant or lactating women. Patients who are lost to follow-up. Other conditions that, in the researcher's assessment, may affect the study or make the subject unsuitable for participation in the study.
结局指标
主要结局
Maximum Standardized uptake value (SUVmax)
时间窗: 1 day from injection of the tracer
Maximum Standardized uptake value (SUVmax) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' primary and/or metastatic lesions.
Mean Standardized Uptake Value(SUVmean) of liver
时间窗: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.
Tumor to Background Ratio(TBR)
时间窗: 1 day from injection of the tracer
TBR=SUVmax/SUVmean
The correlation between CD70 expression and [18F]RCCB6 uptake value
时间窗: 30 days from injection of the tracer
The Standardized uptake value (SUV) of \[68Ga\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[68Ga\]RCCB6 will be analyzed.
次要结局
- Diagnostic value of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC(3-6 months from injection of the tracer)