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Completed

NCT Number: NCT07506161

Radiofrequency Ablation Treatment of Low-Risk Papillary 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.

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Key information

Conditions

Papillary Thyroid Microcarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Premier Med Egészségügyi- Oktató- és Kutatóintézet

Budapest, 1037, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation alone

Procedure

Ultrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of patients with adverse effects

    Time frame: 24 months

    Adverse effects measured during and after the procedure according to SIR AE

  2. Volume reduction ratio

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Premier G Med Cardio Kft

Industry

Collaborators

  • Hungarian Ministry of Innovation and Technology
  • Semmelweis University

Registry information

Official study title

Thermoablation Treatment of Malignant Thyroid Carcinomas

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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