Thyroid CancerNCT06796348
Radiofrequency Ablation Versus Hemithyroidectomy for Small Thyroid Cancers
A study testing Radiofrequency ablation alone and Surgery in people with Thyroid Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
This is a multicenter randomized controlled trial including patients with small (<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Radiofrequency ablation alone and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2025to 1 Dec 2028
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
- tumor size of less than 2 cm in all dimensions.
Who cannot join
- suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
- tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR
- if the patient is pregnant OR
- If the patient is unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lars Rolighed, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated With Hemithyroidectomy or Radiofrequency Ablation.
This is a multicenter randomized controlled trial including patients with small (<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment.
The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.
- Conditions
- Thyroid Cancer
- Being tested
- Radiofrequency ablation alone, Surgery
- Keywords
- Radiofrequency ablation, Hemithyroidectomy, thyroid cancer, Differentiated thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
RFA of a cancer in the thyroid gland.
SurgeryProcedure or surgery
Hemithyroidectomy of the thyroid lobe with cancer
| Study group | Role | What they receive |
|---|---|---|
| Surgery of thyroid cancer | Active comparator | Not described Receives: Procedure: Surgery |
| RFA of thyroid cancer | Experimental | Not described Receives: Procedure: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncomplicated initial treatment (yes/no)
Uncomplicated treatment is defined as a composite endpoint (dichotomous; yes/no) with none of the following adverse outcomes within the first month after treatment/surgery:
- short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy,
- infection with a need for surgical treatment,
- capsule rupture or bleeding with a need for operation,
- prolonged hospital stay (more than one night),
- any other reason for a secondary surgical intervention on the neck.
Measured: One month after randomization.
Secondary outcomes (5)
Oncologic
Any oncologic events with either recurrence of disease in the thyroid gland or lymph node metastasis are included (dichotomous; yes/no). Developing disease in the contralateral side of the thyroid gland will also be described and evaluated and possibly treated. However, contralateral disease will not be classified as adverse outcome after initial treatment but rather classified as new disease (dichotomous; yes/no).
Measured: 5 years after randomization.
Endocrinological 1
The need for substitutional treatment with thyroid hormones (dichotomous; yes/no) is included as secondary endpoint.
Measured: At three months, 1, 2, 3, 4 and 5 years after randomization.
Patient-reported outcome 1
A patient reported outcome is collected with use of the thyroid specific questionnaire ThyPRO-39 (continuous outcome).
Measured: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Health economics
Collective costs for treatment with a HT operation in general anesthesia and an in-hospital stay is much more expensive than RFA treatment in the outpatient clinic. The relation between total costs for HT versus RFA are close to 5:1 and all treatment related costs will be collected during the trial.
Measured: At 5 years after randomization.
Patient-reported outcome 2
A patient reported outcome is collected with use of the thyroid specific questionnaire Voice Related QoL (V-RQoL) (continuous outcome).
Measured: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Sep 2025
- Primary completion28 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796348
- Sponsor's protocol ID
- RFARCT8200
- Status last verified
- Oct 2025
- First submitted
- 17 Dec 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share data of the results from the primary and secondary outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated With Hemithyroidectomy or Radiofrequency Ablation.
- ClinicalTrials.gov ID
- NCT06796348
- Acronym / sponsor ID
- RFARCT8200
- Conditions
- Thyroid Cancer
- Keywords
- Radiofrequency ablation, Hemithyroidectomy, thyroid cancer, Differentiated thyroid carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Jan 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.
This is a multicenter randomized controlled trial including patients with small (<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment.
The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery of thyroid cancer | Active comparator | Procedure: Surgery |
| RFA of thyroid cancer | Experimental | Procedure: Radiofrequency ablation alone |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
- tumor size of less than 2 cm in all dimensions.
Key exclusion criteria (4 listed)
- suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
- tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR
- if the patient is pregnant OR
- If the patient is unable to give informed consent.
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 aloneRFA of a cancer in the thyroid gland. | Procedure or surgery | RFA of thyroid cancer |
| SurgeryHemithyroidectomy of the thyroid lobe with cancer | Procedure or surgery | Surgery of thyroid cancer |
Primary outcome
Uncomplicated initial treatment (yes/no)
Time frame: One month after randomization.
Uncomplicated treatment is defined as a composite endpoint (dichotomous; yes/no) with none of the following adverse outcomes within the first month after treatment/surgery: 1. short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy, 2. infection with a need for surgical treatment, 3. capsule rupture or bleeding with a need for operation, 4. prolonged hospital stay (more than one night), 5. any other reason for a secondary surgical intervention on the neck.
5 secondary outcomes
Oncologic
Time frame: 5 years after randomization.
Endocrinological 1
Time frame: At three months, 1, 2, 3, 4 and 5 years after randomization.
Patient-reported outcome 1
Time frame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Health economics
Time frame: At 5 years after randomization.
Patient-reported outcome 2
Time frame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. We plan to share data of the results from the primary and secondary outcomes.
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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.
Lars Rolighed, MD, PhD contact
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 alone and Surgery in people with Thyroid Cancer, run by University of Aarhus at 1 site in Denmark.
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 2 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 15 Sep 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 Denmark. 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 Sofie Louise Rygaard, MD, PhD (+4551922819, soryga@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncomplicated initial treatment (yes/no) (time frame: One month after randomization.). 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 15 Sep 2026.