Thyroid NoduleNCT06929650
The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer
A study testing Radiofrequency ablation in people with Thyroid Nodule and Thyroid Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients with:
- Nodule less than or equal to 2cm in size
- 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
Who cannot join
- Patients <18 years old
- Pregnant women
- Any concern for invasive or metastatic thyroid cancer
- Previously treated for thyroid cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Saso contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Ilhaan Abdulle, (416) 340-4792, ilhaan.abdulle@uhn.ca
Emily Saso, (613) 854-4420, emily.saso@uhn.ca
About this study
Official title: Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
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.
Read the 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.
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Being tested
- Radiofrequency ablation
- Keywords
- Radiofrequency Ablation, Feasibility, Adverse Event, Thyroid nodule
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Radiofrequency energy is delivered to the thyroid nodule via the medical device. This device is a system consisting of 3 main components:
- VIVA combo RF system (generator and pump)
- single foot switch
- electrode (5mm, 7mm, 10mm, or adjustable).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive RFA intervention for thyroid nodule. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Rate of complications, including pain, burns, recurrent laryngeal nerve palsy, hematoma, nodule rupture, and deviation from euthyroidism
Measured: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.
Secondary outcomes (7)
Effectiveness
Volume reduction rate of thyroid nodule (%)
Measured: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Description of overall symptoms
Measured: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Cosmesis score reduction (scale 0-10 where 0 indicates no issues with cosmesis)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 7-9 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start20 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Pasternak, University Health Network, Toronto
- Investigators
- Jesse D Pasternak, MD, MPH, Principal investigator, University Health Network (UHN) Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929650
- Sponsor's protocol ID
- 21-5788
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
- ClinicalTrials.gov ID
- NCT06929650
- Acronym / sponsor ID
- 21-5788
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Keywords
- Radiofrequency Ablation, Feasibility, Adverse Event, Thyroid nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Radiofrequency ablationParticipants receive RFA intervention for thyroid nodule. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nodule less than or equal to 2cm in size
- Their age is ≥18 years and ≤100 years
- Able to provide written consent
- Able to attend required follow-ups as per the protocol
Key exclusion criteria (4 listed)
- Patients <18 years old
- Pregnant women
- Any concern for invasive or metastatic thyroid cancer
- Previously treated for thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRadiofrequency 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). | Procedure or surgery | Intervention |
Primary outcome
Complications
Time frame: 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
7 secondary outcomes
Effectiveness
Time frame: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Time frame: 4 weeks/6 months/12 months post-procedure.
Effectiveness
Time frame: 4 weeks/6 months/12 months post-procedure.
Quality of life
Time frame: 7-9 months post-procedure.
Quality of life
Time frame: 7-9 months post-procedure.
Quality of life
Time frame: 7-9 months post-procedure.
Quality of life
Time frame: 7-9 months post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Saso contact
Jesse D Pasternak, MD, MPH principal investigator
University Health Network (UHN) Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Thyroid Nodule and Thyroid Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesse Pasternak ((416) 340-4792, jesse.pasternak@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.