EUCTR2013-004033-32-IT进行中（未招募）1 期
AN OPEN, MONOCENTRIC, NOT CONTROLLED CLINICAL TRIAL TO DEVELOP AND EVALUATE THE CLINICAL APPLICATION OF A NEW BETA PROBE FOR RADIOGUIDED SURGERY IN MENINGIOMA TUMOR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- 性别
- All
入选标准
- •-Age >18, male and females
- •-greatest transverse lesion diameter >10mm in Brain MRI or CT scan with and without contrast agents
- •- diagnostic PET/CT with 68Ga-DOTATOC showing a significant uptake in the tumor (>liver) (SSR-positive tumour)
- •-Adequate cardiac function (ECG) and conserved hematological, liver and renal parameters
- •-Before the beginning of the trial, each patient will sign an informed consent
- •-A negative pregnancy test not older than 7 days is mandatory for women in childbearing age
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers)
- •- Documented contrast agents allergy
- •-Pregnancy/breastfeeding
- •- Meningioma recurrences
研究者
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