An interventional study of Radiofrequency ablation in Thyroid Nodule and Thyroid Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
Cost of RFA treatment (probes, human resources, clinic time, complications) compared to traditional thyroidectomy (instruments, human resources, operating room time, hospital stay, complications) will also be compared to historical controls for thyroidectomy costs based on past literature to evaluate the feasibility of RFA as an intervention in this population.
Patients will be given a questionnaire at baseline and post-RFA (\~7-9 months) which includes the following components:
Nodule less than or equal to 2cm in size
a. Specifically: Bethesda 5/6
Exclusion Criteria:
Participants receive RFA intervention for thyroid nodule.
Procedure: Radiofrequency ablation
Radiofrequency energy is delivered to the thyroid nodule via the medical device. This device is a system consisting of 3 main components: 1. VIVA combo RF system (generator and pump) 2. single foot switch 3. electrode (5mm, 7mm, 10mm, or adjustable).
Complications
Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism
Time frame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.
Effectiveness
Volume reduction rate of thyroid nodule (%)
Time frame: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Description of overall symptoms
Time frame: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Cosmesis score reduction (scale 0-10 where 0 indicates no issues with cosmesis)
Time frame: 4 weeks/6 months/12 months post-procedure.
Quality of life
The Body Image Scale is a patient-reported questionnaire used to assess how cancer or its treatment affects a person's perception of their body. It asks about feelings related to appearance, self-consciousness, and changes in how the person views their body after receiving RFA. Responses are given on a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." Higher scores generally indicate greater body image concerns or distress.
Time frame: 7-9 months post-procedure.
Quality of life
The Fear of Progression Questionnaire (FoP-Q) is a validated tool used to assess a patient's anxiety or fear that their illness (thyroid cancer) may worsen or return. It includes questions about emotional, social, and physical concerns related to disease progression. Responses are rated on a 5-point scale: "Never," "Seldom," "Sometimes," "Often," and "Very often." Higher scores reflect greater fear or worry about the illness progressing.
Time frame: 7-9 months post-procedure.
Quality of life
The MD Anderson Symptom Inventory (MDASI) is a validated questionnaire used to assess the severity and impact of cancer-related symptoms on a patient's daily functioning. It includes core symptom items (e.g., pain, fatigue, nausea) rated on a 0-10 scale (0 = not present, 10 = as bad as you can imagine). It also measures how these symptoms interfere with daily life (e.g., general activity, mood, work).
Time frame: 7-9 months post-procedure.
Quality of life
The Decision Regret Scale is used to measure a patient's regret after undergoing RFA. It includes statements rated on a 5-point Likert scale: "Strongly agree" to "Strongly disagree." It assesses whether patients feel that choosing RFA was helpful or if they regret the decision. Higher scores indicate greater regret about the decision.
Time frame: 7-9 months post-procedure.
Plan to share: No
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University Health Network, Toronto