Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

NCT05142904 | Terminated Phase 3

• 1 other identifier: 2021-1798
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hypothyroidism

  Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)

  1 year post-intervention

Secondary Outcomes (7)

• Cure rate

  1 year post-intervention

• Thyroid nodule volume

  Baseline, 6 and 12 months post-intervention

• Treatment related adverse events

  6 weeks and 3, 6 and 12 months post-intervention

• Thyroid related quality of life

  Baseline, 6 and 12 months after intervention

• Cost-effectiveness

  Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention

Other Outcomes (7)

• Health outcomes and quality of life

  Baseline, 6 and 12 months after intervention

• Use of hospital resources

  1 year post-intervention

• Medical consumption

  1 year post-intervention

Study Arms (3)

Radiofrequency ablation

EXPERIMENTAL

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

Device: Radiofrequency ablation

Radioactive iodine, study protocol

ACTIVE COMPARATOR

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

Drug: Radioactive iodine

Radioactive iodine, cohort

OTHER

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).

Drug: Radioactive iodine

Interventions

Radiofrequency ablation DEVICE

Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.

Also known as: RFA, Ultrasound-guided radiofrequency ablation

Radiofrequency ablation

Radioactive iodine DRUG

I-131 according to standardized doses-calculation.

Also known as: I-131

Radioactive iodine, study protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• University of Twente: collaborator
• Amsterdam UMC: collaborator

Study Sites (14)

Ziekenhuis Groep Twente

Almelo, Gelderland, 7609PP, Netherlands

Location

Gelre Hospitals

Apeldoorn, Gelderland, 7334DZ, Netherlands

Location

Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

Location

Laurentius Hospital

Roermond, Limburg, 6043CV, Netherlands

Location

Amphia Hospital

Breda, North Brabant, 4818, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Elkerliek Hospital

Helmond, North Brabant, 5707HA, Netherlands

Location

Amsterdam UMC, location VUMC

Amsterdam, North Holland, 1081HV, Netherlands

Location

OLVG

Amsterdam, North Holland, 1091AC, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM Hoofddorp, Netherlands

Location

Albert Schweiter Hospital

Dordrecht, South Holland, 3318AT, Netherlands

Location

Haaglanden MC

The Hague, South Holland, 2512VA, Netherlands

Location

Haga Ziekenhuizen

Zoetermeer, South Holland, 2725 NA, Netherlands

Location

Martini Hospital

Groningen, 9728 NT Groningen, Netherlands

Location

MeSH Terms

Conditions

Thyroid Nodule; Hyperthyroidism

Interventions

Radiofrequency Ablation; Transurethral Resection of Prostate; Iodine-131

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre 1:1 randomized clinical trial where patients are allocated to either radiofrequency ablation (RFA) or radioactive iodine (RAI) (I-131). Patients who are not suitable for randomization (e.g. no informed consent or contra-indication for RFA) are asked for consent to participate in a prospective cohort where participants are asked to fill out questionaires and data is collected.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 3, 2021
• Study Start: November 17, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (14)