Radiofrequency Ablation Treatment of Low-Risk Papillary Thyroid Carcinomas

March 27, 2026 updated by: Pál Ákos Deák, Premier G Med Cardio Kft

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1037
        • Premier Med Egészségügyi- Oktató- és Kutatóintézet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants are of Hungarian nationality, treated and controlled in the PremierMed Center in Budapest with cytologically confirmed papillary thyroid microcarcinoma

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • uncontrolled hypothyroidism
  • primary hyperparathyroidism
  • calcitonin or serum calcium over the threshold on a repeat blood test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse effects
Time Frame: 24 months
Adverse effects measured during and after the procedure
24 months
Volume reduction ratio
Time Frame: 24 months
Volume reduction ratio: The volume reduction (initial volume minus final volume) compared to the original post-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 reported in mL, calculated using the ellipsoid volume formula: (length x width x depth) x 0.524.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Premier G Med Cardio Kft

Collaborators

Hungarian Ministry of Innovation and Technology
Semmelweis University

Investigators

  • Principal Investigator: Pál Á Deák, MD PhD associate professor, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGYÉI/33486/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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