Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- MRI signal sensitivity to oxygen
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.
PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
- Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.
- Correlate MRI parameters with histology, gene expression, and plasma osteopontin.
- Correlate tumor hypoxia measurements with patient prognosis and treatment response.
OUTLINE:
- Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.
- Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.
- Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.
After completion of study, patients are followed every 3 months for up to 1 year.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BOLD MRI
Determine the amount of oxygen supply to tumors.
干预措施: Standard Care Chemoradiation (Drug)
结局指标
主要结局
MRI signal sensitivity to oxygen
时间窗: 12 weeks
MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
Tumor shrinkage and blood oxygen association
时间窗: 12 weeks
Association between tumor shrinkage and blood oxygen level dependent
次要结局
- Correlate tumor hypoxia with patient prognosis and treatment response(12 weeks)