Radiofrequency Ablation Treatment of Low-Risk Papillary Thyroid Carcinomas

NCT07506161 | Completed

• 1 other identifier: OGYÉI/33486/2021
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Papillary Thyroid Microcarcinoma

Keywords

thermal ablation; radiofrequency; papillary thyroid microcarcinoma; low-risk papillary thyroid carcinoma; mitt; thyroid intervention; Minimally Invasive Thyroid Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (2)

• Number of patients with adverse effects

  24 months

• Volume reduction ratio

  24 months

Interventions

Radiofrequency ablation alone PROCEDURE

Ultrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Premier G Med Cardio Kft: lead
• Hungarian Ministry of Innovation and Technology: collaborator
• Semmelweis University: collaborator

Study Sites (1)

Premier Med Egészségügyi- Oktató- és Kutatóintézet

Budapest, 1037, Hungary

Location

Related Links

• Patient Information Site by the Research Site

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Pál Á Deák, MD PhD associate professor

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, PhD

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 1, 2026
• Study Start: September 9, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

HU (1)