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NCT Number: NCT06796348

Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

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.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Radiofrequency ablation alone

Procedure

RFA of a cancer in the thyroid gland.

Surgery

Procedure

Hemithyroidectomy of the thyroid lobe with cancer

Primary outcomes

  1. Uncomplicated initial treatment (yes/no)

    Time frame: One month after randomization.

    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.

Secondary outcomes

  1. Oncologic

    Time frame: 5 years after randomization.

    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).

  2. Endocrinological 1

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

    The need for substitutional treatment with thyroid hormones (dichotomous; yes/no) is included as secondary endpoint.

  3. Patient-reported outcome 1

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

    A patient reported outcome is collected with use of the thyroid specific questionnaire ThyPRO-39 (continuous outcome).

  4. Health economics

    Time frame: At 5 years after randomization.

    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.

  5. Patient-reported outcome 2

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

    A patient reported outcome is collected with use of the thyroid specific questionnaire Voice Related QoL (V-RQoL) (continuous outcome).

Other outcomes

  1. Endocrinological 2

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

    Thyroid hormones are evaluated by biochemical measurements (mU/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Rolighed, MD, PhD

CONTACT

[email protected]

Sofie Louise Rygaard, MD, PhD

CONTACT

[email protected]

+4551922819

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated with Hemithyroidectomy or Radiofrequency Ablation.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

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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