Radiofrequency ablation versus radioactive iodine as treatment for thyroid lumps that produce too much thyroid hormones.

Phase 1

• Conditions: Patients > 18 years with (subclinical) hyperthyroidism caused by a solitary hyperactive thyroid nodules, either as a solitary hyperactive node in an otherwise normal thyroid gland or as a single hyperactive node in a multinodular goiter.; MedDRA version: 21.1Level: LLTClassification code 10043753Term: Thyroid nodule (toxic)System Organ Class: 100000004860; MedDRA version: 20.0Level: LLTClassification code 10043791Term: Thyrotoxicosis from ectopic thyroid noduleSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-001941-11-NL
• Lead Sponsor: Rijnstate hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-03
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

- Age > 18 years
- (Subclinical) Hyperthyroidism 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

- Multifocal HTN
- HTN >50mm
- Presence of a medical device susceptible to disturbances caused by RFA generated currents
- Inability to complete RAI treatment (e.g. stay in ssafe isolation protection room) or RFA treatment under local anesthesia
- Uncorrectable hemorrhagic diathesis
- Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified