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Ultrasound-guided Radiofrequency Ablation versus radioactive iodine as Treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules

Ultrasound-guided Radiofrequency Ablation versus radioactive iodine as Treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules - RABITO study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54080
Enrollment
232
Registered
2021-08-31
Start date
2021-11-17
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperactive nodule thyroid lump

Interventions

Patients agreeing to participate in randomization will be randomized to receive treatment with either RAI (group 1), or RFA (group 2). Patients declining randomization but agreeing to follow-up will

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age > 18 years - Hyperthyroidism or subclinical hyperthyroidims caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG) - Treatment with RAI indicated and eligible for RFA - Signed informed consent

Exclusion criteria

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 - Uncorrectable hemorrhagic diathesis - Pregnancy

Design outcomes

Primary

MeasureTime frame
Incidence of irreversible hypothyroidism

Secondary

MeasureTime frame
- one year cure rate - course of thyroid function - nodule volume - treatment related thyroiditis - adverse effects - standardized iodine versus local iodine - cost effectiveness - (thyroid related) quality of life - factors for implemantation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)