EUCTR2013-001807-35-DK进行中（未招募）1 期
Imaging with 111In-Octreotide SPECT-CT compared to 68Ga-DOTATATE PET-CT in patients admitted for evaluation of GastroEnteroPancreatic NeuroEndocrine Tumours, GEP-NETs - OCDO-NET
Department of Nuclear Medicine, Odense University Hospital0 个研究点目标入组 100 人开始时间: 2013年8月22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
- 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
- 性别
- All
入选标准
- •Patients referred to the Department of Gastroenterology (dep. S), Odense University Hospital, with suspected GEP-NETs, will at their first appointment receive information about the clinical trial. Formal decision to participate may be made in relation to this information or by response to one of the involved physicians at Dept. S within 48 hours of having received the information. If the patient decides to participate, randomization is performed by the clinical physician at Dept. S to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT with the second examination to be performed within four weeks of the initial examination but with at least five days between the two examinations and prior to possible scheduled surgery. The physician performing the randomization sends a request to the Department of Nuclear Medicine (DNM), Odense University Hospital for both investigations with specification of the sequence as determined by the randomization. The patient is requested to bring the signed consent form when attending for the initial examination. To secure an even distribution between the sequence of the two imaging modalities throughout the trial, the patients are randomized in bulks of 2 and 2 with regards to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT being the initial examination.
- •Patients are included only after written and oral information is given followed by the patients’ signed consent.
- •Fertile women must on each examination day produce a negative pregnancy test prior to injection of the radiopharmaceuticals to remain included in the study.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients below 18 years of age, pregnant or nursing, unwilling, or unable to comply with the protocol or patients with hypersensitivity to any of the substances in the pharmaceuticals are excluded.
研究者
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