Comparing radiofrequency ablation and iodine treatment for thyroid nodules
Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
PHASE3 · Rijnstate Hospital · NCT05142904
This study is testing whether radiofrequency ablation or radioactive iodine works better for treating hyperthyroidism caused by certain thyroid nodules in adults.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 14 sites (Almelo, Gelderland and 13 other locations) |
| Trial ID | NCT05142904 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of radiofrequency ablation (RFA) versus radioactive iodine (I-131) in treating hyperthyroidism caused by solitary autonomous thyroid nodules. Patients over 18 years with specific thyroid conditions will be randomly assigned to receive either treatment. The study will evaluate outcomes based on thyroid function and nodule characteristics, providing insights into the best therapeutic approach for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with hyperthyroidism caused by a solitary hyperactive thyroid nodule that meets specific diagnostic criteria.
Not a fit: Patients with multifocal hyperthyroidism or nodules larger than 50 mm may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients with hyperthyroidism due to solitary thyroid nodules.
How similar studies have performed: Previous studies have shown promising results with radiofrequency ablation for thyroid nodules, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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: * Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels * Anti-TSH antibody negative * Solitary HTN confirmed by a diagnostic I-123 scintigraphy, 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 Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group. Exclusion Criteria: * Multifocal HTN * HTN \> 50 mm * 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 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
Where this trial is running
Almelo, Gelderland and 13 other locations
- Ziekenhuis Groep Twente — Almelo, Gelderland, Netherlands (RECRUITING)
- Gelre Hospitals — Apeldoorn, Gelderland, Netherlands (RECRUITING)
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
- Laurentius Hospital — Roermond, Limburg, Netherlands (RECRUITING)
- Amphia Hospital — Breda, Noord-Brabant, Netherlands (RECRUITING)
- Catharina Hospital — Eindhoven, Noord-Brabant, Netherlands (RECRUITING)
- Elkerliek Hospital — Helmond, Noord-Brabant, Netherlands (RECRUITING)
- Amsterdam UMC, location VUMC — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- OLVG — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- Spaarne Gasthuis — Hoofddorp, Noord-Holland, Netherlands (RECRUITING)
- Haaglanden MC — Den Haag, Zuid Holland, Netherlands (NOT_YET_RECRUITING)
- Albert Schweiter Hospital — Dordrecht, Zuid Holland, Netherlands (RECRUITING)
- Haga Ziekenhuizen — Zoetermeer, Zuid Holland, Netherlands (RECRUITING)
- Martini Hospital — Groningen, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Manon MD van der Meeren, MD
- Email: mvandermeeren@rijnstate.nl
- Phone: 088 005 8888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule, Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction