Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determination of early or a prior prognostic markers of head and neck cancers, as measured by DCE-MRI, DW-MRI, and MRS, that characterize the differences between clinical responders and non-responders.
研究概览
简要总结
The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic resonance imaging (MRI) can help predict how well the tumors will respond to combined chemotherapy and radiation treatment. The investigators hope to find a reliable method to determine whether or not a patient's cancer is responding to chemo-radiation early in their treatment using an MRI, such that that cancer treatments could be tailored to the individual more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI scans: one before the initiation of their regular treatment and the second before their second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.
详细描述
DCE-MRI, DW-MRI, MRS have the potential to measure early cellular changes that occur in response to successful therapies, such as chemoradiation, and have been demonstrated to be early predictors not only of therapeutic response, but also of overall survival for other malignancies. Our long-term goal is to use these imaging techniques to develop non-invasive functional imaging methodologies that would be better predictors of pathological response than the current clinical standard.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed diagnosis of loco-regionally advanced (stage III or IV) squamous cell carcinoma of the head and neck (oropharynx, hypopharynx and larynx)
- •Age > 18 years
- •No prior surgery, chemotherapy or radiation therapy for head and neck cancer
- •Scheduled to receive chemoradiation for definitive therapy
排除标准
- •Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
- •Contraindications to gadolinium
- •Severe, active co-morbidity
- •Major medical illnesses or psychiatric impairments
- •Pregnant or nursing women
结局指标
主要结局
Determination of early or a prior prognostic markers of head and neck cancers, as measured by DCE-MRI, DW-MRI, and MRS, that characterize the differences between clinical responders and non-responders.
时间窗: September 2011
次要结局
- Correlation between early/a prior marker and progression-free survival.(September 2011)
研究者
James Tanyi
Clinical Associate Professor
OHSU Knight Cancer Institute