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Ultrasound-guided Radiofrequency Ablation versus radioactive Iodine as treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules (RABITO study)
EU CTIS ID: 2024-515602-34-01
What this study is testing
To compare the one-year incidence of irreversible hypothyroidism after RAI or RFA treatment for HTN
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics: o Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3/T3 levels o Anti-TSH antibody negative o Solitary HTN confirmed by a diagnostic I-123 or I-131scintigraphy* , corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration < 75%, nodule size <50 mm.
- Treatment with RAI indicated, and eligible for RFA treatment
- Signed informed consent
You likely can't join if
- Multifocal HTN: These patients should be treated according the current standard of care: RAI, surgery or ATD treatment.
- HTN > 50 mm: There is some evidence to suggest that nodule size adversely affects the efficacy of RAI and RFA. Therefore, surgery is recommended as the option of first choice in such cases.
- Insufficient suppression of thyroid tissue on thyroid scintigraphy. Fractional uptake will be determined by the Rijnstate research team. One region of interest (ROI) will be drawn around the whole thyroid and a second ROI around the hot nodule. The counts in these ROI’s will be divided and using a cut-off of ≥0.85 of uptake in the ROI of the nodule.
- Medical history of Graves disease, I-131 treatment, RFA of the same nodule or thyroid malignancy
- Presence of a medical device susceptible to disturbances caused by RFA generated currents.
- Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local or general anesthesia.
See the full eligibility criteria
- Age > 18 years
- Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics: o Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3/T3 levels o Anti-TSH antibody negative o Solitary HTN confirmed by a diagnostic I-123 or I-131scintigraphy* , corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration < 75%, nodule size <50 mm.
- Treatment with RAI indicated, and eligible for RFA treatment
- Signed informed consent
- Multifocal HTN: These patients should be treated according the current standard of care: RAI, surgery or ATD treatment.
- HTN > 50 mm: There is some evidence to suggest that nodule size adversely affects the efficacy of RAI and RFA. Therefore, surgery is recommended as the option of first choice in such cases.
- Insufficient suppression of thyroid tissue on thyroid scintigraphy. Fractional uptake will be determined by the Rijnstate research team. One region of interest (ROI) will be drawn around the whole thyroid and a second ROI around the hot nodule. The counts in these ROI’s will be divided and using a cut-off of ≥0.85 of uptake in the ROI of the nodule.
- Medical history of Graves disease, I-131 treatment, RFA of the same nodule or thyroid malignancy
- Presence of a medical device susceptible to disturbances caused by RFA generated currents.
- Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local or general anesthesia.
- Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility.
- Uncorrectable haemorrhagic diathesis.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.