68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT
研究概览
简要总结
This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.
详细描述
This is a prospective, single-center, single-arm, diagnostic phase 2 study designed to evaluate the efficacy of 68Ga-NYM096 PET/CT in detecting clear cell renal carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Prior to tumor resection, contrast-enhanced CT imaging of the abdomen will be conducted, and if clinically indicated or as part of the local standard of care, imaging of the chest will also be performed. Both imaging modalities (68Ga-NYM096 PET/CT and diagnostic CT) will be completed before kidney resection.
The PET/CT images will be independently interpreted by two blinded readers, while the diagnostic CT images will be evaluated by one blinded reader. The interpretations from both imaging modalities will be compared with histopathologic findings to estimate sensitivity, specificity, and predictive values (primary and secondary objectives). Additionally, the study will explore the performance of 68Ga-NYM096 PET/CT in detecting metastases compared to diagnostic CT. This study aims to provide insights into the diagnostic accuracy of 68Ga-NYM096 PET/CT for identifying ccRCC in patients with complex renal cysts.
The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.
39 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
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
- 否
入选标准
- •Presence of complex renal cyst (Bosniak category II or higher)
- •Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
- •Expected survival of at least 3 months
- •Written informed consent provided for participation in the trial
- •In the opinion of investigator, willing and able to comply with required study procedures.
排除标准
- •On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM
- •If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
- •Intercurrent medical condition that renders the patient ineligible for surgery.
- •Pregnancy or breastfeeding.
- •Severe claustrophobia.
研究组 & 干预措施
68Ga-NYM096 PET/CT
Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
干预措施: 68Ga-NYM096 PET/CT (Diagnostic Test)
结局指标
主要结局
Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT
时间窗: From study completion to 1 month after completion
Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).
Histological classification of operated renal lesions
时间窗: From study completion to 1 month after completion
The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.
次要结局
- Bosniak category of lesion on diagnostic CT(From study completion to 1 month after completion)
- SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT(From study completion to 1 month after completion)
- Intensity of CAIX staining of operated renal lesions(From study completion to 1 month after completion)
- SUVmax of liver uptake on 68Ga-NY104 PET/CT(From study completion to 1 month after completion)
- Tumor grade of operated renal lesions(From study completion to 1 month after completion)
- Extent of CAIX staining of operated renal lesions(From study completion to 1 month after completion)
- Binary reading of renal lesions identified on diagnostic CT(From study completion to 1 month after completion)
- Size of renal lesions identified on diagnostic CT(From study completion to 1 month after completion)
- Number of metastatic lesions identified on 68Ga-NYM096 PET/CT(From study completion to 1 month after completion)
- Location of metastatic lesions identified on 68Ga-NYM096 PET/CT(From study completion to 1 month after completion)
- Size of metastatic lesions identified on 68Ga-NYM096 PET/CT(From study completion to 1 month after completion)
- Number of metastatic lesions identified on diagnostic CT(From study completion to 1 month after completion)
- Location of metastatic lesions on diagnostic CT(From study completion to 1 month after completion)
- Size of metastatic lesions on diagnostic CT(From study completion to 1 month after completion)