Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: Surgery; Procedure: Radiofrequency ablation alone

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Rolighed, MD, PhD; Email: larsroli@rm.dk
• Study Contact Backup: Name: Sofie Louise Rygaard, MD, PhD; Phone Number: +4551922819; Email: soryga@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of Otorhinolaryngology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery of thyroid cancer	Procedure: Surgery; Hemithyroidectomy of the thyroid lobe with cancer
Experimental: RFA of thyroid cancer	Procedure: Radiofrequency ablation alone; RFA of a cancer in the thyroid gland.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month after randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 years after randomization.
Endocrinological 1	The need for substitutional treatment with thyroid hormones (dichotomous; yes/no) is included as secondary endpoint.	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).	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.	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).	At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocrinological 2	Thyroid hormones are evaluated by biochemical measurements (mU/L).	At randomization (baseline), and at three months, 1, 2, 3, 4 and 5 years after randomization.

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Differentiated thyroid carcinoma; thyroid cancer; Radiofrequency ablation; Hemithyroidectomy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: RFARCT8200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share data of the results from the primary and secondary outcomes.
• IPD Sharing Time Frame: Supporting information and IPD will be available by January 2026 and until January 2030.
• IPD Sharing Access Criteria: By contact to the primary investigator and trial manager.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No