Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is:
• What is the feasibility of RFA use for low-risk thyroid cancers (≤2 cm)?
Participants will undergo a set of pre-procedural scans of the target thyroid nodule and undergo the RFA procedure/intervention. Then, participants will partake in three follow-up appointments at 4 weeks, 6 months, and 12 months post-procedure as per standard of care.
详细描述
This is a single center, prospective case series designed to assess the feasibility of RFA therapy (using an investigational RFA device) in a small cohort of participants at University Health Network Toronto. We hypothesize that it will be safe and feasible to use RFA therapy at the University Health Network, Toronto. Further, we believe participants will maintain a good quality of life in the postoperative period, including most avoiding hypothyroidism.
Patients will follow the standard clinical work-up to undergo surgery (e.g. lab parameters and preoperative scans). Patients will - after written informed consent - undergo the RFA procedure.
Within the first year there will be three follow-ups with the participants at:
- 4 weeks
- 6 months
- 12 months post-procedure. After the 12-month follow-up, participants will have follow-up appointments every 6 months until the end of the study.
During these follow-up appointments, the clinician will note any complications or adverse events, and participants will undergo blood sample draws to evaluate serum thyroid stimulating hormone (TSH) concentration. Thyroid nodule size is captured at each follow-up post-procedure via ultrasound, and a re-biopsy may be performed after 12 months to determine if there is material change in the cellular type of the thyroid nodule.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with:
- •Nodule less than or equal to 2cm in size
- •a. Specifically: Bethesda 5/6
- •Their age is ≥18 years and ≤100 years
- •Able to provide written consent
- •Able to attend required follow-ups as per the protocol
排除标准
- •Patients <18 years old
- •Pregnant women
- •Any concern for invasive or metastatic thyroid cancer
- •Previously treated for thyroid cancer
结局指标
主要结局
Complications
时间窗: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.
Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism
次要结局
- Effectiveness(4 weeks/6 months/12 months post-procedure.)
- Quality of life(7-9 months post-procedure.)
研究者
Jesse Pasternak
Principal Investigator
University Health Network, Toronto