EUCTR2014-003873-41-NL进行中（未招募）1 期
on invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial - HX4 several disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Primary tumor site: prostate, esophagus, grade IV glioma or rectum
- •- Metastastic disease to brain (originating from e.g., breast, lung or colorectal primary tumor)
- •-WHO performance status 0 to 2
- •- No chronic renal function failure or no renal dialysis
- •- The patient is willing and capable to comply with study procedures
- •- 18 years or older
- •- Have given written informed consent before patient registration
- •-Histological confirmed prostate tumor
- •-High grade tumor (Gleason score =8)
- •-Macroscopically visual tumor on MRI
- •-Tumorload based on biopsy > 25%
- •-Eligible for HDR-brachytherapy followed by external beam radiotherapy
- •-No previous surgery of the prostate.
- •-No previous radiotherapy of the prostate
- •-No previous chemotherapy or hormonal therapy
- •-Histological or cytological confirmed esophageal tumor
- •-Tumor length = 2,5 cm
- •-No previous surgery to the esophagus
- •-No previous radiotherapy of the esophagus.
- •-No previous chemotherapy.
- •Brain (primary)
- •-Preferably histologically proven, or highly suspicious for malignancy
- •-Primary grade IV glioma (glioblastoma)
- •-Macroscopically visual tumor on MRI ( , diameter larger than 0.5cm)
- •-No complete tumor removal at surgery, only biopsy or partial debulking
- •-no previous chemotherapy
- •Brain (metastases)
- •-brain metastases (originating from the lung, breast or colorectal)
- •-macroscopically visual tumor on MRI (diameter larger than 1.5 cm and suitable for SBRT)
- •-planned for curative treatment with stereotactic body radiotherapy (SBRT)
- •-No chemotherapy 4 weeks before planned scan-date.
- •-Histologically confirmed rectum tumor
- •-tumor size diameter = 2,5 cm
- •-eligible for long-course radiochemotherapy
- •-No previous surgery or radiotherapy of the rectum
- •-No previous chemotherapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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
相似试验
已完成
2 期
on invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trialhersenen, primaire maligne glioom of metastasencancer: several diseases1001799010038597NL-OMON44468MAASTRO Clinic120
尚未招募
2 期
Validation of hypoxia imaging of cancer in the head and neck area with FAZA-PEToropharyngeal cancerNL-OMON32369Antoni van Leeuwenhoek Ziekenhuis20
已完成
不适用
PET With [18F]HX4 in Head and Neck CancerCancer of the Head and NeckNCT01347281Maastricht Radiation Oncology23
终止
2 期
PET CT With HX4 in Cervix CancerCervix CancerNCT02233387Maastricht Radiation Oncology4
终止
2 期
Tumor Hypoxia With HX4 PET in Several DiseasesEsophageal NeoplasmsNeoplasm Metastases, BrainRectal NeoplasmsBrain Neoplasm, PrimaryProstatic NeoplasmsNCT02584400Maastricht Radiation Oncology1