NL-OMON44468已完成2 期
on invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial - HX4 several disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •In order to be eligible to participate in this study, a subject must meet the general and tumor site specific criteria:;General:
- •- Histological/cytological confirmed carcinoma of de esophagus, rectum or prostate or
- •radiological suspicion for Grade IV glioma (primary brain tumor) or brain metastases.
- •- WHO performance status 0 to 2.
- •- Adequate renal function (calculated creatinine clearance at least 60 ml/min).
- •- The patient is willing and capable to comply with study procedures
- •- 18 years or older
- •- Have given written informed consent before patient registration;Prostate
- •- Histological confirmed prostate tumor
- •- High grade tumor (Gleason score *8)
- •- Macroscopically visual tumor on MRI
- •- Tumorload based on biopsy > 25%
- •- No previous surgery of the prostate.
- •- No previous radiotherapy of the prostate
- •- No previous chemotherapy or hormonal therapy;Esophagus
- •- Histological or cytological confirmed adenocarcinoma of the esophagus
- •- Tumor diameter * 2,5 cm
- •- No previous surgery to the esophagus
- •- No previous radiotherapy of the esophagus.
- •- No previous chemotherapy.;Primary brain tumor (Grade IV glioma)
- •- Suspected grade IV glioma on magnetic resonance imaging
- •- Macroscopically visual tumor on MRI (diameter larger than 2 cm)
- •- No previous radiotherapy, chemotherapy or surgery;Brain (metastases)
- •- Raiological suspicion for brain metastases:macroscopically visual tumor on MRI (diameter larger than 2 cm and suitable for SBRT)
- •- Planned for curative treatment with stereotactic body radiotherapy (SBRT);Rectum
- •- Histologically confirmed rectum tumor
- •- Tumor size length * 2,5 cm
- •- Eligible for long-course radiochemotherapy
- •- No previous surgery or radiotherapy of the rectum
- •- No previous chemotherapy
排除标准
- •- Recent (< 3 months) myocardial infarction;- Pregnant or breast feeding and willing to take adequate contraceptive measures during the study
研究者
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