NCT01712685终止2 期
PET Imaging Of Renal Cell Carcinoma With 18F-VM4-037: A Phase II Pilot Study For Detection Of Disease And Correlation With VHL Mutation Status
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
研究概览
简要总结
Background:
- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer.
Objectives:
- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer.
Eligibility:
- Adults at least 18 years of age with kidney cancer that will be treated with surgery.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have two positron emission tomography (PET) scans of their kidneys. They will have the scans before and after receiving an injection of 18F-VM4-037. The scans will take about 2 hours to complete.
- About 3 weeks after the PET scans, participants will provide tumor tissue samples from their kidneys.
- This is a scanning study only. Treatment will not be provided as part of this study.
详细描述
BACKGROUND:
- Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the Von Hippel Lindau (VHL) protein that is commonly overexpressed in certain malignancies including renal cell carcinoma (RCC) and may have prognostic significance.
- The VHL gene is commonly mutated or inactivated in RCC tumors and VHL activity regulated the expression and activity of not only CAIX but also CAXII as well as other genes critical for tumor angiogenesis such as vascular endothelial growth factor (VEGF), glucose transporter 1 (GLUT1), glucose transporter 3 (GLUT 3) and platelet derived growth factor (PDGF).
- 18F-VM4-037 is an imaging drug product formulation which binds to the active site ligand of CA-IX and also binds to CAXII. We propose to evaluate 18F-VM4-037 as a positron emission imaging (PET) radiopharmaceutical for the in vivo detection of CA-IX and CAXII in renal tumors.
STUDY OBJECTIVES
PRIMARY OBJECTIVE:
- To evaluate the biodistribution of 18F-VM4-037 within tumor and non-tumor tissues.
- To assess safety of 18F-VM4-037 in patients with primary or metastatic RCC.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Renal Cell Carcinoma
Experimental
干预措施: 18F-VM4-037 (Drug)
Renal Cell Carcinoma
Experimental
干预措施: PET/CT (Procedure)
结局指标
主要结局
Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
时间窗: 58 days
The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue.
次要结局
- Number of Participants With Adverse Events(58 days)
- Mean Standard Uptake Value (SUV) for All Target Lesions(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
- Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
- Mean Standard Uptake Value (SUV) for Normal Kidney(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
- Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene(21 days prior to enrollment until closure of the study, approximately 14 months.)
- Distribution Volume Ratio (DVR) for the Primary Kidney Lesions(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
- Time to Peak Activity Derived From Time Activity Curve (TAC)(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
- Kinetic (Ki) Rate Constant(Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.)
研究者
Adam Metwalli, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
研究点 (1)
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