Thyroid Papillary CarcinomaPTC-RFANCT07376837
Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study
A study testing Radiofrequency Ablation of Papillary Thyroid Cancer and VIVA combo RF Generator with Coagulation Electrode in people with Thyroid Papillary Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Papillary Carcinoma
- What is being tested?
- Radiofrequency Ablation of Papillary Thyroid Cancer and VIVA combo RF Generator with Coagulation Electrode
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2026to 1 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- ≥18 years old
- Not pregnant at the time of RFA.
- Able to understand and voluntarily sign informed consent.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- Implanted electrical devices such as pacemakers or neurostimulators
- Infection in the neck including skin infection or thyroiditis at time of planned ablation.
- Severe cervical anatomy distortion (prior neck surgery or radiation with distorted anatomy that prevents safe RFA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sangeet Ghai, Division Head, Abdominal Imaging-Dept of Medical Imaging, MD contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario
Sangeet Ghai, MD, sangeet.ghai@uhn.ca
Kateri Corr, 416-946-4501 ext. 5501, kateri.corr@uhn.ca
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Thyroid Papillary Carcinoma
- Being tested
- Radiofrequency Ablation of Papillary Thyroid Cancer, VIVA combo RF Generator with Coagulation Electrode
- Keywords
- Thyroid Radiofrequency Ablation, Minimally Invasive Treatment, Thyroid Papillary Carcinoma, Ultrasound-guided, Low-risk cancer-focused, Thyroid-sparing
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation of Papillary Thyroid CancerProcedure or surgery
Radiofrequency ablation (RFA) is a minimally invasive, image-guided procedure used to destroy targeted thyroid cancer tissue using controlled heat. In this study, RFA is performed percutaneously under real-time ultrasound guidance using an internally cooled radiofrequency electrode inserted into the thyroid tumor through the skin. The procedure is carried out under local anesthesia with conscious sedation.
A standardized moving-shot technique is used to ablate the entire tumor, and hydrodissection may be applied to protect nearby critical structures such as the vocal cord nerve, trachea, and esophagus. RFA is delivered as a single-session treatment with curative intent and is performed on an outpatient basis, with most patients returning home the same day.
This intervention preserves the thyroid gland and avoids surgical incisions. Treatment response is assessed through follow-up imaging, clinical evaluations, patient-reported outcomes, and an ultrasound-guided biopsy of the treated
VIVA combo RF Generator with Coagulation ElectrodeDevice
Also called Southmedic Inc,
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 - VIVA combo RF Generator with Coagulation Electrode
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer | Experimental | 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 Receives: Procedure: Radiofrequency Ablation of Papillary Thyroid Cancer; Device: VIVA combo RF Generator with Coagulation Electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency
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).
Measured: From enrollment to the end of treatment at 12 months.
Safety of the RFA procedure
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.
Measured: From enrollment to the end of treatment at 12 months.
Secondary outcomes (9)
Ultrasound characteristics following RFA
including features used to differentiate successfully treated tumors from residual or recurrent disease
Measured: From enrollment to the end of treatment at 12 months
Tumor volume change over time,
measured by volume reduction ratio (VRR)
Measured: at 6 and 12 months post-RFA
Complication rate of radiofrequency ablation, including but not limited to:
Voice changes, Hematoma, Pain, and Skin burns
Measured: From Treatment to the end of study at 12 months
Patient-reported outcome (Patient Satisfaction)
Patient satisfaction will be assessed using a study-specific questionnaire evaluating satisfaction with the procedure and overall care. Scores range from 1 to 5, with higher scores indicating greater satisfaction (better outcome) and lower scores indicating lower satisfaction.
Measured: From enrollment to the end of study at 12 months.
Patient-reported outcome Voice Handicap Index-10 (VHI-10)
Self-reported Voice Handicap Index-10 (VHI-10): Total score range 0-40; higher scores indicate worse voice-related handicap.
Measured: Time Frame: From enrollment to the end of study at 12 months.
Patient-reported outcome (EORTC QLQ-C30)
The EORTC QLQ-C30 is a validated cancer-specific questionnaire assessing global health status and multiple functional and symptom domains. Scores are transformed to a 0-100 scale. For functional and global health status scales, higher scores indicate better quality of life/functioning, whereas for symptom scales, higher scores indicate worse symptom burden.
Measured: From enrollment to the end of the study at 12 months
Patient Reported outcome - The Assessment of Survivor Concerns (ASC)
The Assessment of Survivor Concerns (ASC) is a validated patient-reported questionnaire designed to evaluate cancer survivors' concerns across multiple domains (e.g., physical, emotional, social, and existential concerns). Total scores range from 0 to 100, with higher scores indicating greater survivor concerns (worse outcomes) and lower scores indicating fewer concerns (better outcomes).
Measured: From enrollment to the end of study at 12 months
Patient-Reported Outcome - Decision Regret Scale (DRS)
Decision regret will be assessed using the Decision Regret Scale (DRS), a validated patient-reported questionnaire measuring distress or remorse after a healthcare decision. Scores are transformed to a 0-100 scale, with higher scores indicating greater decision regret (worse outcome) and lower scores indicating less regret (better outcome).
Measured: From enrollment to the end of study at 12 months
Changes in thyroid biochemical markers over time, including:
Thyroid-stimulating hormone (TSH)
Free T4 (if TSH abnormal)
Thyroglobulin
Thyroglobulin antibody levels
Measured: From enrollment to the end of study at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Papillary CarcinomaStudies 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
- Model description
- This is a single-center, prospective, single-arm interventional pilot study designed to evaluate radiofrequency ablation (RFA) as a curative-intent treatment for small, low-risk papillary thyroid cancer. All enrolled participants receive the same intervention (RFA), with no randomization or comparison group, as the primary purpose is to assess feasibility, safety, and preliminary effectiveness rather than comparative efficacy. Participants undergo a one-time ultrasound-guided RFA procedure, followed by a structured follow-up schedule over 12 months that includes clinical assessments, imaging, laboratory testing, voice evaluations, patient-reported outcome measures, and a biopsy of the treated site at 6-12 months to assess local cancer control. Outcomes are collected prospectively using standardized protocols. As a pilot study, this model is intended to generate high-quality preliminary data to inform the design of future larger, potentially randomized studies comparing RFA with stand
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangeet Ghai, MD, Principal investigator, University Health Network - Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376837
- Sponsor's protocol ID
- 25-5017
- Acronym
- PTC-RFA
- Status last verified
- May 2026
- First submitted
- 15 Jan 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from this study may be shared with qualified researchers upon reasonable request. Data sharing will be considered after completion of the primary analyses and publication of the main study results. Shared data will exclude all direct identifiers and will comply with institutional policies, REB requirements, and applicable privacy legislation. Requests will be reviewed by the study Principal Investigator to ensure scientific validity, ethical appropriateness, and alignment with the original consent. Data will be shared under a data-sharing agreement outlining the permitted use of the data, data security requirements, and restrictions on re-identification or further sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07376837
- Acronym / sponsor ID
- PTC-RFA / 25-5017
- Conditions
- Thyroid Papillary Carcinoma
- Keywords
- Thyroid Radiofrequency Ablation, Minimally Invasive Treatment, Thyroid Papillary Carcinoma, Ultrasound-guided, Low-risk cancer-focused, Thyroid-sparing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Jan 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, prospective, single-arm interventional pilot study designed to evaluate radiofrequency ablation (RFA) as a curative-intent treatment for small, low-risk papillary thyroid cancer. All enrolled participants receive the same intervention (RFA), with no randomization or comparison group, as the primary purpose is to assess feasibility, safety, and preliminary effectiveness rather than comparative efficacy. Participants undergo a one-time ultrasound-guided RFA procedure, followed by a structured follow-up schedule over 12 months that includes clinical assessments, imaging, laboratory testing, voice evaluations, patient-reported outcome measures, and a biopsy of the treated site at 6-12 months to assess local cancer control. Outcomes are collected prospectively using standardized protocols. As a pilot study, this model is intended to generate high-quality preliminary data to inform the design of future larger, potentially randomized studies comparing RFA with stand
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer | Experimental | Procedure: Radiofrequency Ablation of Papillary Thyroid Cancer, Device: VIVA combo RF Generator with Coagulation ElectrodeThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
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 Ablation of Papillary Thyroid CancerRadiofrequency ablation (RFA) is a minimally invasive, image-guided procedure used to destroy targeted thyroid cancer tissue using controlled heat. In this study, RFA is performed percutaneously under real-time ultrasound guidance using an internally cooled radiofrequency electrode inserted into the thyroid tumor through the skin. The procedure is carried out under local anesthesia with conscious sedation. A standardized moving-shot technique is used to ablate the entire tumor, and hydrodissection may be applied to protect nearby critical structures such as the vocal cord nerve, trachea, and esophagus. RFA is delivered as a single-session treatment with curative intent and is performed on an outpatient basis, with most patients returning home the same day. This intervention preserves the thyroid gland and avoids surgical incisions. Treatment response is assessed through follow-up imaging, clinical evaluations, patient-reported outcomes, and an ultrasound-guided biopsy of the treated | Procedure or surgery | Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer |
| VIVA combo RF Generator with Coagulation ElectrodeAlso: Southmedic Inc,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 - VIVA combo RF Generator with Coagulation Electrode | Device | Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer |
Primary outcome
Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency
Time frame: 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
Time frame: 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.
9 secondary outcomes
Ultrasound characteristics following RFA
Time frame: From enrollment to the end of treatment at 12 months
Tumor volume change over time,
Time frame: at 6 and 12 months post-RFA
Complication rate of radiofrequency ablation, including but not limited to:
Time frame: From Treatment to the end of study at 12 months
Patient-reported outcome (Patient Satisfaction)
Time frame: From enrollment to the end of study at 12 months.
Patient-reported outcome Voice Handicap Index-10 (VHI-10)
Time frame: Time Frame: From enrollment to the end of study at 12 months.
Patient-reported outcome (EORTC QLQ-C30)
Time frame: From enrollment to the end of the study at 12 months
Patient Reported outcome - The Assessment of Survivor Concerns (ASC)
Time frame: From enrollment to the end of study at 12 months
Patient-Reported Outcome - Decision Regret Scale (DRS)
Time frame: From enrollment to the end of study at 12 months
Changes in thyroid biochemical markers over time, including:
Time frame: From enrollment to the end of study at 12 months.
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 19 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) from this study may be shared with qualified researchers upon reasonable request. Data sharing will be considered after completion of the primary analyses and publication of the main study results. Shared data will exclude all direct identifiers and will comply with institutional policies, REB requirements, and applicable privacy legislation. Requests will be reviewed by the study Principal Investigator to ensure scientific validity, ethical appropriateness, and alignment with the original consent. Data will be shared under a data-sharing agreement outlining the permitted use of the data, data security requirements, and restrictions on re-identification or further sharing.
Related trials for Thyroid Papillary Carcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Not yet recruiting
Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial
Differentiated Thyroid Gland Carcinoma, Malignant Testicular Neoplasm
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.
Sangeet Ghai, Division Head, Abdominal Imaging-Dept of Medical Imaging, MD contact
Sangeet Ghai, MD principal investigator
University Health Network - Toronto General Hospital
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 of Papillary Thyroid Cancer and VIVA combo RF Generator with Coagulation Electrode in people with Thyroid Papillary Carcinoma, 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 9 inclusion and 13 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 19 May 2026. 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 Kateri Corr (416-500-5737, kateri.corr@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency (time frame: From enrollment to the end of treatment at 12 months.). The study lists 2 primary outcomes in all. 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 19 May 2026.