NCT03498183已完成2 期
Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (Sup or Egal to 15 mm) Classified Bethesda III or IV on Cytology
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 5
- 主要终点
- Addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase the negative predictive value compared to the dual tracer scintigraphy alone.
研究概览
简要总结
The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.
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
- •Any patient over 18 years with a thyroid nodule ≥15 mm (maximal diameter measured on US) with a Bethesda class III or IV (FNA less than 6 months before the surgery).
- •Given signed, written informed consent
- •Affiliation to a social security system.
- •Neither-pregnant nor breast-feeding women.
- •Use of efficient contraception for patient with pregnancy potential (if needed).
排除标准
- •Underage and adults under guardianship.
- •Pregnant, without efficient contraception (if needed) or breast feeding women.
- •Administration of iodinated contrast in the previous 3 weeks.
- •Contraindication to scintigraphy or to Iodine123/ MIBI 99Tc administration
- •Treatment containing iodine (i.e. : Amiodarone)
- •Hypo or hyperthyroidism treated or not.
- •Nodules inferior 15 mm.
- •Refusal to sign the consent.
- •Refusal of surgical treatment or contraindication for surgery or anesthesia
- •Morbid obesity (BMI Superior 40 kg/m2).
- •Hyperparathyroidism.
- •History of cervicotomy.
研究组 & 干预措施
ARM experimental
Experimental
All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.
干预措施: MIBI-Tc99m/Iodine-123 (Drug)
结局指标
主要结局
Addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase the negative predictive value compared to the dual tracer scintigraphy alone.
时间窗: Month 36
Scintigraphy MIBI-Tc99m/Iodine-123
次要结局
- Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).(Month 36)
- Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.(Month 36)
- Evaluation of diagnostics properties of Ti-RADS scoring.(Month 36)
- Evaluation of the MIBI washout(Month 36)
- Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.(Month 36)
- Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.(year 10)
研究者
研究点 (5)
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