NCT02810600已完成不适用
Phase II Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke1 个研究点 分布在 1 个国家目标入组 2,120 人开始时间: 2016年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,120
- 试验地点
- 1
- 主要终点
- Record all adverse events
研究概览
简要总结
Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. Each included patient will receive an administered dose of 50 mcg or less of the peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.
The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected or proven tumors expressing Somatostatin receptors
- •Informed consent by patient (or parents if patient is less than 18 years of age)
排除标准
- •Pregnancy (confirmed). In the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure.
- •Patient refusal to participate.
- •Impossibility to tolerate a decubitus position for 25 minutes
- •Prior allergic reaction to DOTA-TATE or somatostatin analogs
结局指标
主要结局
Record all adverse events
时间窗: June 2016-June 2018
次要结局
未报告次要终点
研究者
研究点 (1)
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