NCT02432599已完成2 期
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Centre Francois Baclesse4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Sensitivity (ability to identify and visualize the parathyroid adenoma)
研究概览
简要总结
The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or more;
- •Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
- •Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
- •Affiliate to a social security system;
- •Patient written informed consent.
排除标准
- •Patient deprived of liberty, under guardianship;
- •Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
- •Pregnant or breastfeeding
结局指标
主要结局
Sensitivity (ability to identify and visualize the parathyroid adenoma)
时间窗: Up to 2 months
Sensitivity of PET-CT with F18-choline (FCH) to identify and visualize the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory parathyroid scintigraphy MIBI and cervical ultrasound
次要结局
未报告次要终点
研究者
研究点 (4)
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