Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules (RABITO)

Rijnstate Hospital

Status and phase: Terminated; Phase 3

Conditions: Iodine Adverse Reaction; Thyroid Nodule; Hyperthyroidism; Thyroid Nodule, Toxic or With Hyperthyroidism; Radiofrequency Ablation; Autonomous Thyroid Function; Iodine Hyperthyroidism

Treatments: Device: Radiofrequency ablation; Drug: Radioactive iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT05142904

2021-1798

Details and patient eligibility

About

The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Radiofrequency ablation

Experimental group

Description:

Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.

Treatment:

Device: Radiofrequency ablation

Radioactive iodine, study protocol

Active Comparator group

Description:

Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.

Treatment:

Drug: Radioactive iodine

Drug: Radioactive iodine

Radioactive iodine, cohort

Other group

Description:

This group contains patients who are not randomized and have given informed consent undergo treatment with radioactive iodine (I-131) according to local standard (e.g. fixed dose or dose-calculation based on iodine uptake and thyroid nodule mass).

Treatment:

Drug: Radioactive iodine

Drug: Radioactive iodine