Initial Evaluation of Anti-1-amino-F-18 Flurocyclobutane-1carboxylic Acid (Anti-18F-FACBC) in the Assessment of Head and Neck Cancer: A Pilot Study.
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- The presence of FACBC radiotracer uptake in Head and neck tumors on PET scans
研究概览
简要总结
The purpose of this study is to assess a relatively new PET (Positron emission tomography) radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer. These limitations include problems with specificity, high background uptake from normal structures, difficulty delineating intracranial invasion, and the need to wait several weeks after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA (Food and Drug Administration) approval, but does show promise in initial work in patients with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.
Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical resection (ie, surgery without preceding chemotherapy or radiation). Patients must have pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who consent to participate will receive one FACBC PET/CT of the neck, which will require a low dose "transmission" CT of the neck, an intravenous injection of the radiotracer, and imaging of the neck that will last up to 1 hour. Patients will have to lie still during the imaging time. Total participation time including set up should be less than 90 minutes. Imaging results will be analyzed and compared with conventional imaging as well as the surgical pathology results
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
- •Age 18 years or older.
- •Biopsy proven, untreated squamous cell carcinoma of the oral cavity.
- •Clinical, laboratory, or diagnostic imaging findings on CT, MRI, or 18F-FDG PET/CT.
- •Ability to lie still for PET scanning.
- •Able to provide written informed consent.
排除标准
- •Age less than 18 years.
- •Prior history of carcinoma.
- •Not a candidate for surgical resection based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
- •Inability to lie still for PET scanning.
- •Inability to provide written informed consent.
研究组 & 干预措施
FACBC
干预措施: FACBC (Drug)
结局指标
主要结局
The presence of FACBC radiotracer uptake in Head and neck tumors on PET scans
时间窗: 1 day
The results of the FACBC PET scan will be validated by direct comparison with the pathology findings obtained at surgery. .
次要结局
未报告次要终点
研究者
David M. Schuster, MD
Principal Investigator
Emory University
