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Study Comparing Radiofrequency Ablation and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Overactive Thyroid Nodules

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of hyperthyroidism caused by solitary autonomous thyroid nodules. Hyperthyroidism is a condition where the thyroid gland is overactive, producing too much thyroid hormone. The study compares two treatments: ultrasound-guided radiofrequency ablation and radioactive iodine therapy. Radioactive iodine, also known as sodium iodide (131I), is a chemical substance used to treat hyperthyroidism by reducing the activity of the thyroid gland.

The purpose of the study is to compare the effects of these treatments over one year, particularly looking at the occurrence of a condition called irreversible hypothyroidism, where the thyroid becomes underactive. Participants will receive either the radiofrequency ablation or the radioactive iodine treatment. The study will monitor various health outcomes, including thyroid function, nodule size, and quality of life, at different intervals over the course of a year.

Throughout the study, participants will undergo regular check-ups to assess their thyroid function and overall health. The study aims to provide valuable information on the effectiveness and safety of these treatments for managing hyperthyroidism caused by solitary thyroid nodules. This research could help improve treatment options and outcomes for individuals with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The initial assessment involves confirming eligibility for the study. This includes being over 18 years old and having hyperthyroidism caused by a solitary hyperactive thyroid nodule.

    A blood test will be conducted to check thyroid hormone levels, including TSH, FT4, and FT3. An ultrasound and a diagnostic scan using I-123 or I-131 will confirm the presence of a solitary thyroid nodule.

  2. Step 2

    Treatment allocation

    Participants will be randomly assigned to receive either radioactive iodine (RAI) treatment or radiofrequency ablation (RFA).

    For those receiving RAI, sodium iodide (131I) will be administered orally in capsule form. The dosage will range from 0.329 to 3.7 MBq, depending on individual requirements.

  3. Step 3

    Treatment administration

    The RAI treatment involves taking the sodium iodide (131I) capsule orally. The frequency and duration will be determined by the healthcare provider based on the specific needs of the participant.

    Participants receiving RFA will undergo a procedure guided by ultrasound to target the thyroid nodule.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will occur at 6 weeks, and 3, 6, and 12 months after treatment. These will include blood tests to monitor thyroid hormone levels and ultrasound scans to assess nodule size.

    Additional assessments will include checking for any treatment-related adverse events and evaluating thyroid-related quality of life using questionnaires.

  5. Step 5

    Final evaluation

    At the end of the first year, a final evaluation will be conducted to determine the cumulative incidence of irreversible hypothyroidism and the overall cure rate.

    The final evaluation will also include a review of health outcomes, quality of life, and the use of healthcare resources over the year.

Who can join the trial?

6 criteria

  • Must be older than 18 years.
  • Have a condition called **hyperthyroidism** or **subclinical hyperthyroidism** caused by a single overactive thyroid nodule. This nodule can be in a normal thyroid gland or in a thyroid with multiple nodules. The diagnosis is based on:
    • Blood **TSH level** (a hormone that controls the thyroid) is below normal, with normal or high levels of **FT4** and **FT3/T3** (thyroid hormones).
    • Negative for **anti-TSH antibodies** (these are proteins that can affect the thyroid).
    • A single overactive thyroid nodule confirmed by a special scan using I-123 or I-131, which matches a clearly defined thyroid nodule seen on an ultrasound. The nodule should have less than 75% cystic degeneration (fluid-filled areas) and be smaller than 50 mm.
    • Eligible for treatment with **RAI** (Radioactive Iodine) and also suitable for **RFA** (Radiofrequency Ablation) treatment.
    • Must have signed an informed consent form, which means you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Individuals with a history of **hyperactive thyroid nodules** cannot participate. These are small lumps in the thyroid gland that produce too much thyroid hormone.
  • Participants must be within a specific age range, which is not specified here.
  • Both **male** and **female** participants are eligible, but certain conditions may exclude them.
  • Individuals who are considered part of a **vulnerable population** are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Radiofrequency Ablation (RFA)

    is a treatment that uses heat generated by radio waves to destroy abnormal thyroid tissue. In this trial, it is guided by ultrasound to precisely target the thyroid nodule causing hyperthyroidism. The goal is to reduce the size of the nodule and alleviate symptoms without affecting the rest of the thyroid gland.

  • Radioactive Iodine (RAI)

    is a treatment that involves taking a small dose of radioactive iodine by mouth. The iodine is absorbed by the thyroid gland, where it gradually destroys the overactive thyroid cells. This treatment aims to reduce the activity of the thyroid nodule and control hyperthyroidism.

What is already known about the treatment

  • Radioactive Iodine

    This medication is administered orally, typically in the form of a capsule or liquid. It is currently well-established in medical practice and literature for treating hyperthyroidism, particularly in cases involving hyperactive thyroid nodules. The main therapeutic indication is to reduce thyroid hormone production by selectively destroying overactive thyroid tissue. At the molecular level, radioactive iodine is absorbed by the thyroid gland, where it emits radiation that damages the overactive cells. It is classified as a radiopharmaceutical used in nuclear medicine.

  • Radiofrequency Ablation

    This treatment is applied through a minimally invasive procedure using ultrasound guidance to target hyperactive thyroid nodules. It is gaining recognition in medical literature as an alternative to traditional treatments for hyperthyroidism. The primary therapeutic indication is to reduce the size and activity of thyroid nodules by applying heat to destroy the problematic tissue. The mechanism of action involves the use of high-frequency electrical currents to generate heat, causing thermal damage to the targeted cells. It is classified as a non-surgical, image-guided ablation technique.

Investigated diseases

Hyperactive Thyroid Nodules – These are lumps in the thyroid gland that produce excess thyroid hormones, leading to an overactive thyroid state. The nodules can cause symptoms such as increased heart rate, weight loss, and nervousness due to the elevated hormone levels. Over time, the nodules may grow in size, potentially causing discomfort or difficulty swallowing. The condition is often monitored through regular thyroid function tests and imaging to assess changes in nodule size and activity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515602-34-01Protocol codeNL77101.091.21Estimated enrolment232 patientsSponsorRijnstate Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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