Benign neoplasm of thyroid gland Trials in Disease

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

This clinical trial focuses on treating hyperthyroidism caused by a single overactive thyroid nodule. When a benign thyroid nodule becomes hyperactive, it produces too much thyroid hormone, leading to symptoms such as increased heart rate, weight loss, and nervousness.

Main inclusion criteria: To participate in this study, you must be over 18 years old and have hyperthyroidism or subclinical hyperthyroidism caused by a single overactive thyroid nodule. This diagnosis is confirmed through blood tests showing low TSH levels (the hormone that controls the thyroid) with normal or high levels of thyroid hormones FT4 and FT3. You must also test negative for anti-TSH antibodies. A special scan using I-123 or I-131 must confirm the presence of a single overactive nodule that matches what is seen on an ultrasound. The nodule should be smaller than 50 mm and have less than 75% fluid-filled areas. You must be suitable for both treatment approaches being studied and willing to sign an informed consent form.

Main exclusion criteria: You cannot participate if you have a history of hyperactive thyroid nodules. The study also excludes individuals who fall into vulnerable populations, such as those unable to provide informed consent.

Focus and goal: The study compares two treatment approaches over one year. The first is ultrasound-guided radiofrequency ablation, which uses heat generated by radio waves to destroy the abnormal thyroid tissue. The second is radioactive iodine therapy, where you take a small dose of radioactive iodine by mouth, which is absorbed by the thyroid gland and gradually destroys the overactive cells. The primary goal is to compare how often each treatment leads to irreversible hypothyroidism, a condition where the thyroid becomes underactive. The study will also monitor thyroid function, nodule size, quality of life, and overall health outcomes at various intervals throughout the year.

Investigational treatments: The two treatments being compared are Radiofrequency Ablation (RFA) and Radioactive Iodine (RAI), also known as sodium iodide (131I). Radiofrequency ablation is a minimally invasive procedure that uses ultrasound guidance to precisely target and destroy the overactive thyroid nodule with heat. Radioactive iodine is administered orally in capsule form, with dosages ranging from 0.329 to 3.7 MBq depending on individual needs. Both treatments aim to reduce thyroid nodule activity and control hyperthyroidism without affecting the rest of the thyroid gland.

Throughout the study, participants will undergo regular follow-up assessments at 6 weeks, and at 3, 6, and 12 months after treatment. These assessments include blood tests to monitor thyroid hormone levels, ultrasound scans to measure nodule size, and questionnaires to evaluate quality of life. Healthcare providers will also monitor for any treatment-related side effects.