FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
研究概览
简要总结
This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.
详细描述
PRIMARY OBJECTIVES:
I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma.
II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma.
OUTLINE:
Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).
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
- •Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation
- •Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
- •Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
- •Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter
排除标准
- •Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
- •Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT
- •Subjects incapable of giving informed written consent, for the following reasons:
- •Inability to adhere to the experimental protocols for any reason
- •Inability to communicate with the research team
- •Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
- •Prisoners or other individuals deemed to be susceptible to coercion
结局指标
主要结局
Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
时间窗: Baseline to the completion of 6 courses of treatment
The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.
次要结局
- Progression-free Survival (PFS)(Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years)
- Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation(Baseline to day 21)
- Objective Response (OR)(Day 84)
研究者
Thomas Yankeelov
Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research
Vanderbilt-Ingram Cancer Center