The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Permeability, perfusion, diffusion and glucose metabolism
研究概览
简要总结
Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.
详细描述
Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0)
- •Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx
- •Curative intent concurrent chemoradiation
- •Age > 18 years
- •Karnofsky Performance Status > 60
- •Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan
排除标准
- •Diabetes other than diet controlled
- •MRI Absolute Contraindications including:
- •Glomerular filtration rate < 60 ml/min
- •Weight < 350 lb or current device limitations
- •Metallic foreign bodies in the eye
- •Cardiac pacemakers
- •Clips in the central nervous system (ferromagnetic haemostatic)
- •Automatic internal cardiac defibrillators
- •Cochlear implants
- •Shrapnel in vital locations
- •Pregnant (positive pregnancy test) or lactating
结局指标
主要结局
Permeability, perfusion, diffusion and glucose metabolism
时间窗: At end of 1 week of radiation therapy
次要结局
- Relationships between baseline and treatment induced changes in vascular permeability, perfusion, interstitial space, glucose metabolism, and saliva production to identify prognostic and predictive parameter(s) for treatment(1 year of completing radiation therapy)