In short
There is currently 1 ongoing clinical trial focused on treating thyroid mass conditions, specifically targeting hyperthyroidism caused by overactive thyroid nodules. This trial is being conducted in the Netherlands and compares two different treatment approaches: radiofrequency ablation and radioactive iodine therapy.
Clinical trial locations
Study Comparing Radiofrequency Ablation and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Overactive Thyroid Nodules
This clinical trial is examining different ways to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. Specifically, the study focuses on cases where hyperthyroidism is caused by a single overactive thyroid nodule, which is a small lump in the thyroid gland.
Who can participate:
- Adults over 18 years of age
- Individuals with hyperthyroidism or subclinical hyperthyroidism caused by a single overactive thyroid nodule
- Blood tests showing low TSH levels with normal or high FT4 and FT3/T3 levels
- Negative test results for anti-TSH antibodies
- Confirmation of a single overactive nodule through a special scan using I-123 or I-131 that matches an ultrasound finding
- The nodule must be less than 50 mm in size and have less than 75% fluid-filled areas
- Must be suitable for both radioactive iodine and radiofrequency ablation treatments
- Must provide signed informed consent
Who cannot participate:
- People with a history of hyperactive thyroid nodules
- Individuals outside the specified age range
- Vulnerable populations, such as children, pregnant women, or those unable to provide consent
What the trial involves:
The study compares two treatment methods over the course of one year. Participants will be randomly assigned to receive either radiofrequency ablation or radioactive iodine therapy. Radiofrequency ablation uses heat generated by radio waves to destroy abnormal thyroid tissue, guided by ultrasound to precisely target the nodule. Radioactive iodine, also known as sodium iodide (131I), is taken orally as a capsule and works by being absorbed by the thyroid gland, where it gradually destroys overactive thyroid cells.
Throughout the study, participants will undergo regular check-ups at 6 weeks, and at 3, 6, and 12 months after treatment. These assessments will include blood tests to monitor thyroid hormone levels, ultrasound scans to check nodule size, and questionnaires to evaluate quality of life and any side effects from treatment.
Trial goals:
The main goal of this trial is to compare the effectiveness and safety of these two treatments, particularly looking at whether patients develop irreversible hypothyroidism, a condition where the thyroid becomes underactive. The study also aims to assess the cure rate, changes in nodule size, thyroid function, quality of life, and the overall use of healthcare resources over the year-long period.
Investigational treatments:
The trial uses two established treatments: Radiofrequency Ablation (RFA), which is a minimally invasive procedure that uses high-frequency electrical currents to generate heat and destroy overactive thyroid tissue, and Radioactive Iodine (RAI), which is a radiopharmaceutical that selectively damages overactive thyroid cells through radiation after being absorbed by the thyroid gland.
Summary
Currently, there is one active clinical trial for thyroid mass, specifically targeting hyperthyroidism caused by overactive thyroid nodules. This trial is being conducted in the Netherlands and represents an important comparison between two established treatment approaches: radiofrequency ablation and radioactive iodine therapy. The study aims to provide valuable information about the effectiveness and safety of these treatments, which could help improve treatment options for individuals with this condition. Patients interested in participating should meet specific eligibility criteria related to their age, thyroid condition, and suitability for both treatments being studied.
