Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

NCT06796348 | Not Yet Recruiting DMC

• 1 other identifier: RFARCT8200
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

Radiofrequency ablation; Hemithyroidectomy; thyroid cancer; Differentiated thyroid carcinoma

Outcome Measures

Primary Outcomes (1)

• 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: 1. short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy, 2. infection with a need for surgical treatment, 3. capsule rupture or bleeding with a need for operation, 4. prolonged hospital stay (more than one night), 5. any other reason for a secondary surgical intervention on the neck.

  One month after randomization.

Secondary Outcomes (5)

• Oncologic

  5 years after randomization.

• Endocrinological 1

  At three months, 1, 2, 3, 4 and 5 years after randomization.

• Patient-reported outcome 1

  At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.

• Health economics

  At 5 years after randomization.

• Patient-reported outcome 2

  At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.

Other Outcomes (1)

• Endocrinological 2

  At randomization (baseline), and at three months, 1, 2, 3, 4 and 5 years after randomization.

Study Arms (2)

Surgery of thyroid cancer

ACTIVE COMPARATOR

Procedure: Surgery

RFA of thyroid cancer

EXPERIMENTAL

Procedure: Radiofrequency ablation alone

Interventions

Radiofrequency ablation alone PROCEDURE

RFA of a cancer in the thyroid gland.

RFA of thyroid cancer

Surgery PROCEDURE

Hemithyroidectomy of the thyroid lobe with cancer

Surgery of thyroid cancer

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Otorhinolaryngology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Radiofrequency Ablation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques

Central Study Contacts

Sofie Louise Rygaard, MD, PhD

CONTACT

+4551922819; soryga@rm.dk

Lars Rolighed, MD, PhD

CONTACT

larsroli@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting information and IPD will be available by January 2026 and until January 2030.
• Access Criteria: By contact to the primary investigator and trial manager.

Locations

DK (1)