Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
研究概览
简要总结
This study investigates fluorine-18-AlphaVBeta6-BP ([18F]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that [18F]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.
详细描述
PRIMARY OBJECTIVE:
The primary objective of this study is to evaluate the sensitivity and specificity of [18F]-αvβ6-BP PET/CT for detecting metastases in patients with NSCLC.
OUTLINE:
Patients will undergo [18F]-αvβ6-BP PET/CT at baseline in addition to standard-of-care [18F]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT body and magnetic resonance imaging (MRI) of the brain. Patients will then undergo standard-of-care cancer directed therapy. Patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with [18F]-αvβ6-BP PET/CT, [18F]-FDG PET/CT, and MRI.
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 age >18 yrs
- •Biopsy proven NSCLC with brain metastases (treated or untreated)
- •Life-expectancy of ≥3 months in the opinion of the treating physician
- •Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.
- •Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan
- •Ability to understand and willingness to sign a written informed consent document.
- •Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
- •[18F]-FDG PET/CT within 21 days of enrollment
- •MRI brain within 21 days of enrollment
- •Eastern Cooperative Oncology Group Performance Status ≤ 2
- •Glomerular filtration rate (GFR) ≥ 60
排除标准
- •Pregnant or lactating women
- •Concurrent malignancy of a different histology that could confound imaging interpretation
- •Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
研究组 & 干预措施
Experimental [18F]-αvβ6-BP
Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
干预措施: [18F]-αvβ6-BP (Drug)
结局指标
主要结局
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
时间窗: Up to six months
Standard uptake value (SUV) values from \[18F\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \[18F\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC
次要结局
- Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment(Up to six months)
- Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging(Up to six months)
- Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging(Up to six months)
研究者
Julie L. Sutcliffe, Ph.D
Professor of Internal Medicine and Biomedical Engineering
University of California, Davis