Clinical trial NCT05142904: Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Official title: Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Nodule, Toxic or With Hyperthyroidism
Autonomous Thyroid Function
Thyroid Nodule; Hyperthyroidism
Radiofrequency Ablation
Iodine Hyperthyroidism
Iodine Adverse Reaction
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: University of Twente
name: Amsterdam UMC
First posted: 2021-12-03
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Hypothyroidism
timeFrame: 1 year post-intervention
Secondary outcomes:
measure: Cure rate
timeFrame: 1 year post-intervention
measure: Thyroid nodule volume
timeFrame: Baseline, 6 and 12 months post-intervention
measure: Treatment related adverse events
timeFrame: 6 weeks and 3, 6 and 12 months post-intervention
measure: Thyroid related quality of life
timeFrame: Baseline, 6 and 12 months after intervention
measure: Cost-effectiveness
timeFrame: Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention
measure: Course of thyroid function
timeFrame: Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.
measure: Short-term patient satisfaction
timeFrame: 1 week and 1 year post-intervention
Other outcomes:
measure: Health outcomes and quality of life
timeFrame: Baseline, 6 and 12 months after intervention
measure: Use of hospital resources
timeFrame: 1 year post-intervention
measure: Medical consumption
timeFrame: 1 year post-intervention
measure: Use of healthcare resources
timeFrame: 1 year post-intervention
measure: Cumulative cost
timeFrame: 1 year post-intervention
measure: Fractional nodal uptake
timeFrame: 1 year post-intervention
measure: Treatment related auto-immunity
timeFrame: Baseline and 1 year post-intervention
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuis Groep Twente
state: Gelderland
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
state: Gelderland
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Roermond
country: Netherlands
facility: Laurentius Hospital
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Elkerliek Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Den Haag
country: Netherlands
facility: Haaglanden MC
state: Zuid Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweiter Hospital
state: Zuid Holland
city: Zoetermeer
country: Netherlands
facility: Haga Ziekenhuizen
state: Zuid Holland
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
References: