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临床试验/NCT01933269
NCT01933269撤回早期 1 期

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.

Emory University0 个研究点开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David M. Schuster, MD

Principal Investigator

Emory University

相似试验

FACBC for Head and Neck Cancers | 临床试验