EUCTR2020-002205-26-CZ进行中（未招募）1 期
[68Ga] -SomaKIT-TOC PET / CT in postoperative evaluation of meningioma residues in the cranial base area - [68Ga]-SomaKIT-TOC] PET/CT
Fakultní nemocnice u sv. Anny v Brne0 个研究点目标入组 30 人开始时间: 2020年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1. age =18 years
- •2. histologically proven diagnosis of WHO grade I-III meningioma in the area of ??the base of the skull
- •3. condition after cranial meningioma surgery in the previous 20 years
- •4. stage of Simpson II - V resection (ie patients with Simpson I resection will not be included, in whom the complete tumor has been clearly removed, including the surrounding dura mater and bone to a sufficient extent)
- •5. signed informed consent
- •6. ECOG PS 0-2
- •7. laboratory values:
- •7.1. bilirubin <1.5x upper limit of normal
- •7.2. creatinine <1.5x upper limit of normal
- •7.3. urea <1.5x upper limit of normal
- •7.4. platelets> 50x 10 to 9 / l
- •8. ability to undergo MR and PET / CT examinations
- •9. the ability of the assessment body to cooperate as required by the Protocol
- •10. participants in a clinical trial of childbearing potential must agree to the use of prescribed methods of contraception for at least one month following a single dose of study medication
- •women - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse, ev. the presence of bilateral tubal occlusion or vasectomy in the partner
- •men - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in case of sexual intercourse
- •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
- •1. known hypersensitivity to any component of the investigational product according to SPC
- •2. history of severe forms of polyvalent allergy
- •3. inability to undergo MR examination (neurostimulator, pacemaker, cochlear implant, metal implant of unclear anamnesis, metal chips in the eye)
- •4. morbid obesity or deformity of the torso preventing passage through the opening of the CT or MR device
- •5. claustrophobia or inability to lie down for 20 minutes without moving
- •6. the presence of any mental, family, social or geographical facts that could impede the procedure in accordance with the protocol - these facts must be discussed with the subject before inclusion in the clinical trial
研究者
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