In short
There is currently 1 ongoing clinical trial for toxic nodular goitre, comparing two treatment approaches for managing hyperthyroidism caused by overactive thyroid nodules. The trial is taking place in the Netherlands and evaluates radiofrequency ablation versus radioactive iodine therapy.
Clinical trial locations
Study Comparing Radiofrequency Ablation and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Overactive Thyroid Nodules
This trial is designed for patients with hyperthyroidism caused by solitary autonomous thyroid nodules, which are lumps in the thyroid gland that produce too much thyroid hormone. The study compares two different treatment options to help manage this condition.
Who can participate:
- Adults over 18 years of age
- Individuals with hyperthyroidism or subclinical hyperthyroidism caused by a single overactive thyroid nodule
- The diagnosis must be confirmed through blood tests showing low TSH levels with normal or high FT4 and FT3/T3 levels, and negative anti-TSH antibodies
- The nodule must be visible on ultrasound and confirmed as overactive through a special scan using I-123 or I-131
- The nodule should be smaller than 50 mm and have less than 75% fluid-filled areas
- Patients must be suitable candidates for both radioactive iodine treatment and radiofrequency ablation
Who cannot participate:
- Individuals with a previous history of hyperactive thyroid nodules
- People outside the specified age range
- Vulnerable populations, such as those unable to provide informed consent
What the trial studies:
The trial evaluates two treatment approaches for managing overactive thyroid nodules. Participants will be randomly assigned to receive either radioactive iodine therapy or radiofrequency ablation. The main goal is to compare how these treatments affect thyroid function over one year, particularly focusing on whether patients develop irreversible hypothyroidism, a condition where the thyroid becomes underactive.
The study monitors various outcomes including thyroid hormone levels, nodule size, quality of life, and any side effects from treatment. Follow-up assessments occur at 6 weeks, 3 months, 6 months, and 12 months after treatment, involving blood tests, ultrasound scans, and questionnaires about quality of life.
Investigational treatments:
The trial compares two approaches:
- Radioactive Iodine (RAI): This involves taking sodium iodide (131I) orally in capsule form. The radioactive iodine is absorbed by the thyroid gland, where it gradually destroys overactive thyroid cells. The dosage ranges from 0.329 to 3.7 MBq, depending on individual needs.
- Radiofrequency Ablation (RFA): This is a minimally invasive procedure guided by ultrasound that uses heat generated by radio waves to destroy the abnormal thyroid tissue. The goal is to reduce the nodule size and control symptoms without affecting the rest of the thyroid gland.
Summary
Currently, there is one clinical trial available for patients with toxic nodular goitre. The trial is being conducted in the Netherlands and focuses on comparing two established treatment methods: radiofrequency ablation and radioactive iodine therapy. Both treatments aim to reduce thyroid hormone production and manage symptoms of hyperthyroidism caused by overactive thyroid nodules.
The study is particularly interested in understanding the long-term effects of these treatments, including the risk of developing hypothyroidism and the overall effectiveness in controlling the condition. This research may help healthcare providers and patients make more informed decisions about treatment options for managing overactive thyroid nodules.
