NCT02784223已完成不适用
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.
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
- •Age ≥ 18 years
- •Patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the Bethesda Classification 2008 (vesicular lesion of undetermined significance (Bethesda 3); follicular neoplasm or Hürthle cells (Bethesda 4); lesion suspicious for malignancy (Bethesda 5)), and to be operated on
- •Patient affiliated to a social security scheme
- •Informed consent and signed
排除标准
- •Thyroid nodules <15 mm
- •Coalescing nodules preventing proper individualization of targeted nodule;
- •Thyroid nodule with non-diagnostic cytology (Bethesda 1), benign cytology (Bethesda 2) or malignant cytology (Bethesda 6)
- •Hot thyroid nodule on the thyroid scan
- •Major subject to a measure of legal protection or unable to consent
- •Pregnant women / nursing
- •Refusal to participate
研究组 & 干预措施
PET-CT with F18-choline
Experimental
PET-CT with F18-choline examination will be performed before surgery
干预措施: Radiation : PET-CT with F18-choline examination (Device)
结局指标
主要结局
Sensitivity
时间窗: Up to 4 months
Sensitivity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
Specificity
时间窗: Up to 4 months
Specificity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
次要结局
- Predictive diagnostic capabilities(Up to 4 months)
- Duration for acquisition(Up to 4 months)
研究者
研究点 (2)
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