68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Histological classification of operated renal lesions
研究概览
简要总结
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.
详细描述
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NY104 PET/CT in comparison to diagnostic CT will also be performed.
The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.
63 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 a renal mass
- •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-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY
- •If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- •Intercurrent medical condition that renders the patient ineligible for surgery.
- •Pregnancy or breastfeeding.
- •Severe claustrophobia.
结局指标
主要结局
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.
Binary reading of renal lesions identified on 68Ga-NY104 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).
次要结局
- Binary reading of renal lesions identified on diagnostic CT(From study completion to 1 month after completion)
- Location of metastatic lesions identified on 68Ga-NY104 PET/CT(From study completion to 1 month after completion)
- Number of metastatic lesions on diagnostic CT(From study completion to 1 month after completion)
- SUVmax of renal lesions identified on 68Ga-NY104 PET/CT(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)
- Intensity of CAIX staining 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)
- Size of renal lesions identified on diagnostic CT(From study completion to 1 month after completion)
- Szie of metastatic lesions identified on 68Ga-NY104 PET/CT(From study completion to 1 month after completion)
- Number of metastatic lesions identified on 68Ga-NY104 PET/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)