Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

NCT ID: NCT06796348

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgery of thyroid cancer

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

Hemithyroidectomy of the thyroid lobe with cancer

RFA of thyroid cancer

Group Type: EXPERIMENTAL

Radiofrequency ablation alone

Intervention Type: PROCEDURE

RFA of a cancer in the thyroid gland.

Interventions

Radiofrequency ablation alone

RFA of a cancer in the thyroid gland.

Intervention Type: PROCEDURE

Surgery

Hemithyroidectomy of the thyroid lobe with cancer

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Otorhinolaryngology, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Central Contacts

Sofie Louise Rygaard, MD, PhD

Role: CONTACT

soryga@rm.dk

+4551922819

Lars Rolighed, MD, PhD

Role: CONTACT

larsroli@rm.dk

Other Identifiers

RFARCT8200

Identifier Type: -

Identifier Source: org_study_id