Evaluating the Feasibility, Safety and Efficacy of Radiofrequency Ablation (RFA) for Curative Treatment of Small Low-Risk Thyroid Papillary Cancer: A Pilot Single Arm Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency
概览
简要总结
This pilot, single-arm clinical study evaluates the feasibility, safety, and effectiveness of radiofrequency ablation (RFA) as a curative treatment for small, low-risk papillary thyroid cancer (PTC). The study will enroll 30 adult patients (≥18 years) with biopsy-confirmed PTC measuring <2 cm, who decline surgery or active surveillance, or who are transitioning from active surveillance to active treatment.
Eligible participants will undergo ultrasound-guided RFA performed with curative intent at University Health Network. Patients will be followed for up to 12 months with scheduled clinical visits, neck ultrasounds, blood tests, voice assessments, and patient-reported outcome questionnaires. A biopsy of the ablation site at 6-12 months will be used to assess local cancer control.
The primary objective is to determine the local cure rate and safety profile of RFA for low-risk PTC. Secondary objectives include evaluating post-ablation ultrasound features, patient-reported quality of life, and the feasibility of implementing a multidisciplinary thyroid RFA program within routine clinical practice.
Results from this study will provide important preliminary data to inform future larger trials comparing RFA with surgery and active surveillance for selected patients with low-risk papillary thyroid cancer.
详细描述
This study is a pilot clinical trial designed to evaluate a less invasive treatment option for adults with small, low-risk papillary thyroid cancer (PTC). PTC is the most common type of thyroid cancer and is often slow growing with an excellent prognosis. Standard treatment usually involves surgery to remove part or all of the thyroid gland. While surgery is highly effective, it may be associated with complications such as voice changes, low calcium levels, prolonged recovery, and the need for lifelong thyroid hormone replacement. For some patients, close monitoring without treatment (active surveillance) is an option, but this approach can cause ongoing anxiety and uncertainty.
Radiofrequency ablation (RFA) is a minimally invasive, image-guided procedure that uses controlled heat to destroy targeted tissue. RFA has been widely used to treat benign thyroid nodules and is increasingly being explored as a treatment for carefully selected small thyroid cancers. This study aims to determine whether RFA can safely and effectively eliminate small PTCs while preserving the thyroid gland and reducing the impact of treatment on patients' daily lives.
The study will enroll 30 adult participants (18 years or older) with biopsy-confirmed papillary thyroid cancer measuring less than 2 cm, with no evidence of spread outside the thyroid or to lymph nodes. All participants will have previously been offered standard treatment options and have chosen not to undergo surgery or active surveillance, or will be transitioning from active surveillance to active treatment. Each potential participant will be reviewed by a multidisciplinary team that includes radiology, endocrinology, and surgical specialists to ensure the treatment is appropriate and safe.
The RFA procedure will be performed on an outpatient basis under local anesthesia and light sedation, using real-time ultrasound guidance to precisely target the cancer while protecting nearby structures such as the vocal cords, trachea, and esophagus. Patients are typically observed briefly after the procedure and can return home the same day.
Following treatment, participants will be followed closely for up to 12 months. Follow-up includes clinic visits, neck ultrasound examinations, blood tests to assess thyroid function, voice assessments, and questionnaires that evaluate symptoms, quality of life, satisfaction with treatment, and decision-related concerns. A key component of follow-up is an ultrasound-guided biopsy of the treated area performed 6 to 12 months after RFA, which will be used to determine whether the cancer has been successfully eradicated.
The primary focus of the study is to assess local cancer control and safety of RFA, including the frequency and severity of any complications. Additional goals include understanding how treated thyroid cancers appear on ultrasound over time, evaluating patient-reported outcomes, and assessing the practicality of delivering and sustaining a multidisciplinary thyroid RFA program within a Canadian academic health-care setting.
The results of this study will provide important early evidence on the role of radiofrequency ablation as a potential alternative to surgery for selected patients with low-risk papillary thyroid cancer and will help guide future larger clinical trials and treatment guidelines.
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
- •Histologically confirmed papillary thyroid carcinoma (PTC) by fine-needle aspiration (FNA -Bethesda V/VI ) or core needle biopsy.
- •Single or multiple lesions, each 2.0 cm in maximum diameter.
- •Intrathyroidal tumors (i.e., no extrathyroidal extension, no clinical/radiological evidence of nodal metastases, nor distant metastases).
- •Lesions located at a safe distance (\>2 mm) from critical structures (e.g., trachea, esophagus, carotid artery) or accessible with hydrodissection.
- •≤T1b (i.e. \< 2cm maximal diameter), N0 or Nx, M0 (no clinical or radiological evidence of lymph node or distant metastasis).
- •Patients unfit for surgery due to comorbidities or who refuse surgery.
- •≥18 years old
- •Not pregnant at the time of RFA.
- •Able to understand and voluntarily sign informed consent.
排除标准
- •Evidence of lymph node involvement (clinically or radiologically suspicious or confirmed metastatic nodes) or distant metastasis (e.g., lung, bone).
- •Tumors with extrathyroidal extension
- •Tumors with extensive calcification
- •Tumors located within 2 mm of critical structures where RFA would pose an unacceptably high risk and where hydrodissection is not feasible.
- •Previous thyroid surgery or ablation (RFA, ethanol, laser, or microwave) at the index tumor site.
- •Known diagnosis of anaplastic, poorly differentiated, or other aggressive thyroid cancer variants.
- •Pregnant or breastfeeding at the time of enrollment.
- •Bleeding diathesis or use of anticoagulants that cannot be discontinued safely prior to RFA.
- •Severe comorbid illness that limits life expectancy to less than 5 years.
- •Inability to adhere to study follow-up schedule or procedures or lacking decision-making capacity.
研究组 & 干预措施
Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer
This single study arm includes adult participants with biopsy-confirmed, low-risk papillary thyroid cancer (<2 cm) who undergo curative-intent radiofrequency ablation (RFA) of the thyroid tumor. RFA is performed once, on an outpatient basis, using a percutaneous, ultrasound-guided approach with an internally cooled radiofrequency electrode. The procedure is carried out under local anesthesia with conscious sedation, using a standardized moving-shot technique, with hydrodissection as needed to protect adjacent structures.
No study drugs are administered as part of this intervention. The RFA procedure is a one-time treatment, although repeat ablation may be considered if residual disease is identified during follow-up, based on clinical judgment and participant consent.
All participants in this arm follow the same post-procedure monitoring and follow-up schedule, which includes clinical assessments, neck ultrasound, thyroid blood tests, voice evaluation, patient-reported outcome quest
干预措施: Radiofrequency Ablation of Papillary Thyroid Cancer (Procedure)
Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer
This single study arm includes adult participants with biopsy-confirmed, low-risk papillary thyroid cancer (<2 cm) who undergo curative-intent radiofrequency ablation (RFA) of the thyroid tumor. RFA is performed once, on an outpatient basis, using a percutaneous, ultrasound-guided approach with an internally cooled radiofrequency electrode. The procedure is carried out under local anesthesia with conscious sedation, using a standardized moving-shot technique, with hydrodissection as needed to protect adjacent structures.
No study drugs are administered as part of this intervention. The RFA procedure is a one-time treatment, although repeat ablation may be considered if residual disease is identified during follow-up, based on clinical judgment and participant consent.
All participants in this arm follow the same post-procedure monitoring and follow-up schedule, which includes clinical assessments, neck ultrasound, thyroid blood tests, voice evaluation, patient-reported outcome quest
干预措施: VIVA combo RF Generator with Coagulation Electrode (Device)
结局指标
主要结局
Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency
时间窗: From enrollment to the end of treatment at 12 months.
Local cure rate of papillary thyroid cancer (PTC) following radiofrequency ablation, assessed by ultrasound-guided fine needle aspiration or core biopsy of the ablation site at 6-12 months, with local cure defined as no evidence of malignancy on biopsy (when diagnostic material is obtained).
Safety of the RFA procedure
时间窗: From enrollment to the end of treatment at 12 months.
Safety of the RFA procedure, measured by the incidence and nature of procedure-related complications, including but not limited to voice changes, hematoma, pain, skin burns, and other adverse events.
次要结局
- Ultrasound characteristics following RFA(From enrollment to the end of treatment at 12 months)
- Tumor volume change over time,(at 6 and 12 months post-RFA)
- Complication rate of radiofrequency ablation, including but not limited to:(From Treatment to the end of study at 12 months)
- Patient-reported outcome (Patient Satisfaction)(From enrollment to the end of study at 12 months.)
- Patient-reported outcome Voice Handicap Index-10 (VHI-10)(Time Frame: From enrollment to the end of study at 12 months.)
- Patient-reported outcome (EORTC QLQ-C30)(From enrollment to the end of the study at 12 months)
- Patient Reported outcome - The Assessment of Survivor Concerns (ASC)(From enrollment to the end of study at 12 months)
- Patient-Reported Outcome - Decision Regret Scale (DRS)(From enrollment to the end of study at 12 months)
- Changes in thyroid biochemical markers over time, including:(From enrollment to the end of study at 12 months.)