NCT04623801进行中（未招募）2 期
Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with complete thermal ablation
研究概览
简要总结
The purpose of this study is to explore whether percutaneous laser ablation (PLA) is a safe and effective alternative to removing papillary thyroid microcarcinoma (PTMC) with surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Papillary thyroid cancer documented by
- •(a) Bethesda VI cytology,
- •(b) Bethesda III, IV, V, or VI cytology AND BRAF V600E mutation, or
- •(c) Bethesda V cytology AND high risk ultrasonographic features documented by either the ATA high suspicion or TIRADS 5 nodule characteristics
- •To ensure the majority of cases will be eligible based on criteria (a) or (b), we will enroll ≤ 2 patients based on criteria (c).
- •Maximum diameter ≤ 13 mm
- •Declined active surveillance
- •The thyroid lesion must be primarily solid with ≤ 25% cystic compent
- •No US evidence of extrathyroidal extension through the thyroid capsule
- •No imaging evidence of lymph node metastasis
- •Preserved contralateral vocal cord function prior to PLA
排除标准
- •Thyroid cancer that is non papillary thyroid cancer (PTC)
- •Thyroid lesion with > 25% cystic component
- •Lesion with US evidence of extrathyroidal extension through the thyroid capsule
- •Clinical or ultrasonographic evidence of lymph node metastasis
- •Pregnancy
研究组 & 干预措施
Participants with papillary microcarcinoma (PTMC)
Experimental
Participants with papillary microcarcinoma (PTMC) who have elected to proceed with thyroidectomy rather than an observational management approach will be considered as potential candidates for this trial.
干预措施: Percutaneous Laser Ablation (PLA) (Procedure)
结局指标
主要结局
Number of participants with complete thermal ablation
时间窗: 6 months
Complete thermal ablation of the targeted PTMC (T1aN0M0) as determined by histological examination of thyroid tissue obtained by either thyroid lobectomy or total thyroidectomy 6 months after PLA.
次要结局
未报告次要终点
研究者
研究点 (1)
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