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The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer

Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06929650
Enrollment
40
Registered
2025-04-16
Start date
2023-04-20
Completion date
2025-12-31
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Thyroid Nodule

Keywords

Radiofrequency Ablation, Feasibility, Adverse Event, Thyroid nodule

Brief summary

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.

Detailed description

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. 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: * thyroid cancer treatment status; * the Decision Regret Scale (0 to 100) where 100 represents maximal regret (only post-RFA); * the Fear of Progression Questionnaire- Short Form questionnaire (focused on thyroid cancer disease progression); * the Hospital Anxiety and Depression Scale (HADS); * the MD Anderson Symptom Inventory for thyroid cancer (MDASI-Thy), a disease-specific quality of life questionnaire; and * the Body Image Scale (BIS), a questionnaire on body image perception for cancer patients.

Interventions

PROCEDURERadiofrequency 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).

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1\. 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

Exclusion criteria

* Patients \<18 years old * Pregnant women * Any concern for invasive or metastatic thyroid cancer * Previously treated for thyroid cancer

Design outcomes

Primary

MeasureTime frameDescription
ComplicationsImmediately 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

Secondary

MeasureTime frameDescription
Effectiveness4 weeks/6 months/12 months post-procedure.Volume reduction rate of thyroid nodule (%)
Quality of life7-9 months post-procedure.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.

Countries

Canada

Contacts

Primary ContactJesse Pasternak
jesse.pasternak@uhn.ca(416) 340-4792
Backup ContactEmily Saso
emily.saso@uhn.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026