NCT01447134Unknown不适用
Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
Chang Gung Memorial Hospital0 个研究点目标入组 100 人开始时间: 2011年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
研究概览
简要总结
- Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
- Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.
详细描述
This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head and neck cancer patients (including nasopharyngeal cancer)
- •Age equals or more than 20 years old
- •Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
- •Willing to sign the informed consent
排除标准
- •Patient who is pregnant or lactating;
- •Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
- •Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
- •Unable to give informed consent
研究者
Tzu-Chen Yen
Department of Nuclear Medicine
Chang Gung Memorial Hospital
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