Papillary Thyroid MicrocarcinomaNCT07506161
Radiofrequency Ablation Treatment of Low-Risk Papillary Thyroid Carcinomas
An observational study of Papillary Thyroid Microcarcinoma, run by Premier G Med Cardio Kft at 1 site in Hungary.
Trial summary
Researchers in this study aim to prove the safety and efficacy of radiofrequency ablation in the treatment of a carefully selected low-risk papillary thyroid microcarcinoma patient group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- What is being tested?
- Radiofrequency ablation alone
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteHungary
- Study dates
- 9 Sep 2021to 31 Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All participants are of Hungarian nationality, treated and controlled in the PremierMed Center in Budapest with cytologically confirmed papillary thyroid microcarcinoma
Who may be able to join
- Adult patients with cytologically confirmed papillary thyroid carcinoma with the longest diameter of less than or equal to 10 mms in T1aN0M0 clinical stage without metastases and without cytological signs of aggressivity AND
- Patients objecting to both surgery and active surveillance
Who cannot join
- History of or active disease: neck irradiation, stroke, CV disease, CNS vascular malformation, any malignant disease, immunocompromised state, recurrent laryngeal nerve paresis, organ failure
- extrathyroidal extension of tumor (including capsular)
- pregnancy
- lesion less than 5 mm close to the danger zone
- safety margin could not be obtained (min 2mm)
- uncontrolled hyperthyroidism
Show all 9Show fewer
- uncontrolled hypothyroidism
- primary hyperparathyroidism
- calcitonin or serum calcium over the threshold on a repeat blood test
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Premier Med Egészségügyi- Oktató- és Kutatóintézet
Budapest, 1037
About this study
Official title: Thermoablation Treatment of Malignant Thyroid Carcinomas
Researchers in this study aim to prove the safety and efficacy of radiofrequency ablation in the treatment of a carefully selected low-risk papillary thyroid microcarcinoma patient group.
- Conditions
- Papillary Thyroid Microcarcinoma
- Being tested
- Radiofrequency ablation alone
- Keywords
- thermal ablation, radiofrequency, papillary thyroid microcarcinoma, low-risk papillary thyroid carcinoma, mitt, thyroid intervention, Minimally Invasive Thyroid Treatment
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
Ultrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients without clinical evidence of a tumor on ultrasound and cytology on the treatment site
We measure the number of patients without clinical evidence of a papillary thyroid microcarcinoma at the treatment site, evaluated with a (B-mode) ultrasound scan and a contrast-enhanced ultrasound scan of the whole tyroid and cytology reports from a fine needle aspiration from the site of the treatment at 24 months post-ablation.
Measured: 24 months
Secondary outcomes (2)
Number of patients with adverse effects
Adverse effects measured during and after the procedure according to SIR AE
Measured: 24 months
Volume reduction ratio
Volume reduction ratio: The volume reduction (pre-ablation volume minus final volume) compared to the pre-ablation volume, times 100. Volumes are measured on ultrasound. Length, width and depth is determined using the longest diameters on 3 perpendicular planes. Volume is calculated using the ellipsoid volume formula: (length x width x depth) x π/6.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start9 Sep 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid MicrocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Premier G Med Cardio Kft
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Innovation and Technology, Hungary, Semmelweis University
- Responsible party
- Principal investigator, Pál Ákos Deák, Premier G Med Cardio Kft
- Investigators
- Pál Á Deák, MD PhD associate professor, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506161
- Sponsor's protocol ID
- OGYÉI/33486/2021
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoablation Treatment of Malignant Thyroid Carcinomas
- ClinicalTrials.gov ID
- NCT07506161
- Acronym / sponsor ID
- OGYÉI/33486/2021
- Conditions
- Papillary Thyroid Microcarcinoma
- Keywords
- thermal ablation, radiofrequency, papillary thyroid microcarcinoma, low-risk papillary thyroid carcinoma, mitt, thyroid intervention, Minimally Invasive Thyroid Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Premier G Med Cardio KftIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Innovation and Technology, Hungary, Semmelweis University
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Apr 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.
Researchers in this study aim to prove the safety and efficacy of radiofrequency ablation in the treatment of a carefully selected low-risk papillary thyroid microcarcinoma patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants are of Hungarian nationality, treated and controlled in the PremierMed Center in Budapest with cytologically confirmed papillary thyroid microcarcinoma
Key inclusion criteria (2 listed)
- Adult patients with cytologically confirmed papillary thyroid carcinoma with the longest diameter of less than or equal to 10 mms in T1aN0M0 clinical stage without metastases and without cytological signs of aggressivity AND
- Patients objecting to both surgery and active surveillance
Key exclusion criteria (9 listed)
- History of or active disease: neck irradiation, stroke, CV disease, CNS vascular malformation, any malignant disease, immunocompromised state, recurrent laryngeal nerve paresis, organ failure
- extrathyroidal extension of tumor (including capsular)
- pregnancy
- lesion less than 5 mm close to the danger zone
- safety margin could not be obtained (min 2mm)
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 aloneUltrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas | Procedure or surgery | – |
Primary outcome
The number of patients without clinical evidence of a tumor on ultrasound and cytology on the treatment site
Time frame: 24 months
We measure the number of patients without clinical evidence of a papillary thyroid microcarcinoma at the treatment site, evaluated with a (B-mode) ultrasound scan and a contrast-enhanced ultrasound scan of the whole tyroid and cytology reports from a fine needle aspiration from the site of the treatment at 24 months post-ablation.
2 secondary outcomes
Number of patients with adverse effects
Time frame: 24 months
Volume reduction ratio
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Patient Information Site by the Research SiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Papillary Thyroid Microcarcinoma
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
Active, not recruitingPhase 2
Laser Ablation of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma, Thyroid
RecruitingObservational study
RFA Treatment for Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
Not yet recruiting
Decision Aid Efficacy in Low Risk Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma
RecruitingObservational study
Genomic Predictors of Papillary Microcarcinoma Disease Progression
Papillary Microcarcinoma
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. This study is not recruiting at the moment.
Pál Á Deák, MD PhD associate professor principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Microcarcinoma, run by Premier G Med Cardio Kft at 1 site in Hungary.
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 9 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: finished, as of the sponsor's last update on 9 Jun 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients without clinical evidence of a tumor on ultrasound and cytology on the treatment site (time frame: 24 months). 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 9 Jun 2026.