Clinical trial NCT06796348: Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers
Official title: Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated with Hemithyroidectomy or Radiofrequency Ablation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Keywords: Radiofrequency ablation
Hemithyroidectomy
thyroid cancer
Differentiated thyroid carcinoma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Uncomplicated initial treatment (yes/no)
timeFrame: One month after randomization.
Secondary outcomes:
measure: Oncologic
timeFrame: 5 years after randomization.
measure: Endocrinological 1
timeFrame: At three months, 1, 2, 3, 4 and 5 years after randomization.
measure: Patient-reported outcome 1
timeFrame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
measure: Health economics
timeFrame: At 5 years after randomization.
measure: Patient-reported outcome 2
timeFrame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Other outcomes:
measure: Endocrinological 2
timeFrame: At randomization (baseline), and at three months, 1, 2, 3, 4 and 5 years after randomization.
Locations:
city: Aarhus
country: Denmark
facility: Department of Otorhinolaryngology, Aarhus University Hospital
Study officials:
References: