Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of metastatic lesions
研究概览
简要总结
Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.
详细描述
This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 26 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.
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
- •Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)
- •Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).
- •Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure
排除标准
- •Pregnant or breastfeeding
- •Age less than 18
- •Histology does not have any clear cell component
- •Unable to lie flat for 30 minutes for the scan
- •History of prior malignancy (except non-melanoma skin cancer)
- •Unable to provide informed consent
- •Inadequate liver function
- •Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place
- •Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)
结局指标
主要结局
Number of metastatic lesions
时间窗: 5 weeks from initial baseline conventional imaging
To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.
Change in management
时间窗: 1 month
To determine the proportion of patients in which results from the PSMA-PET imaging changes management.
次要结局
- Pathologic correlates(1 month or not applicable)
研究者
Melissa Huynh
Assistant Professor
Western University