SODIUM IODIDE (131I) for Hyperthyroidism | Solitary hyperactive (hot) thyroid nodule

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- 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: o\tBlood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3/T3 levels o\tAnti-TSH antibody negative o\tSolitary HTN confirmed by a diagnostic I-123 or I-131scintigraphy* , corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration < 75%, nodule size <50 mm.\n- Treatment with RAI indicated, and eligible for RFA treatment\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Multifocal HTN: These patients should be treated according the current standard of care: RAI, surgery or ATD treatment.\n- HTN > 50 mm: There is some evidence to suggest that nodule size adversely affects the efficacy of RAI and RFA. Therefore, surgery is recommended as the option of first choice in such cases.\n- Insufficient suppression of thyroid tissue on thyroid scintigraphy. Fractional uptake will be determined by the Rijnstate research team. One region of interest (ROI) will be drawn around the whole thyroid and a second ROI around the hot nodule. The counts in these ROI’s will be divided and using a cut-off of ≥0.85 of uptake in the ROI of the nodule.\n- Medical history of Graves disease, I-131 treatment, RFA of the same nodule or thyroid malignancy\n- Presence of a medical device susceptible to disturbances caused by RFA generated currents.\n- Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local or general anesthesia.\n- Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility.\n- Uncorrectable haemorrhagic diathesis.\n- Pregnant or breastfeeding women."}

Primary endpoints

• {"endpoint_text":"- Cumulative incidence of irreversible hypothyroidism in the first year after intervention. Irreversible primary hypothyroidism is defined as: 1) (A)symptomatic elevation of TSH levels in the range of 5 - 10 mU/L for at least 10-12 weeks and without signs of recovery, confirmed by repeated measurements; or as (a)symptomatic hypothyroidism with TSH levels > 10 mU/L for more than 4 weeks, without signs of recovery, confirmed on at least two separate occasions.","definition_or_measurement_approach":"Irreversible primary hypothyroidism defined by TSH and symptoms: (1) (A)symptomatic elevation of TSH 5-10 mU/L for at least 10-12 weeks without recovery, confirmed by repeated measurements; or (2) (a)symptomatic hypothyroidism with TSH > 10 mU/L for >4 weeks, confirmed on at least two separate occasions."}

Secondary endpoints

• {"endpoint_text":"- Cure rate at 1 year, complete cure is defined as a normalization of TSH, FT4 and FT3 /T3levels.\n- Thyroid nodule volume assessed by ultrasound at baseline, 6, and 12 months.\n- Fractional nodal uptake assessed by I-123 or I-131 scintigraphy, at baseline and 12 months.\n- Thyroid antibodies at 0 and 12 months, to monitor treatment-related autoimmunity.\n- Treatment related adverse events, number of adverse and serious adverse events at 6 weeks, and 3, 6 and 12 months.\n- Thyroid related quality of life, assessed by ThyPro questionnaire at baseline, and 6 and 12 months after treatment.\n- Health outcomes and quality of life at one year, based on the European QoL-5 Dimensions (EQ-5D-5L) questionnaire\n- Use of health care resources during the first year after treatment, according to medical records, iMCQ and iPCQ.\n- Cumulative costs at 1 year\n- Cost-effectiveness at 1 year is determined as the incremental costs in Euros per quality adjusted life year (QALY), assessed by the European QoL-5 Dimensions (EQ-5D-5L) at baseline and 6 weeks, 3, 6, 9 and 12 months after treatment and use of health care resources during the first 12 months\n- Course of thyroid function as assessed by TSH, FT4 and FT3 at baseline and during a one year follow-up with an extension of follow-up up to 5 years\n- Short-term patient satisfaction assessed by interviews, a satisfaction questionnaire, pain scoring by visual analog scale (VAS).","definition_or_measurement_approach":"Cure rate: normalization of TSH, FT4 and FT3/T3 at 1 year. Nodule volume: ultrasound at baseline, 6 and 12 months. Fractional uptake: I-123 or I-131 scintigraphy at baseline and 12 months. Thyroid antibodies: measured at 0 and 12 months. AEs/SAEs: counted at 6 weeks, 3, 6 and 12 months. ThyPro questionnaire at baseline, 6 and 12 months for thyroid-related QoL. EQ-5D-5L for health outcomes at 1 year. Health resource use via medical records, iMCQ and iPCQ during first year. Costs and cost-effectiveness (incremental cost per QALY) assessed using EQ-5D-5L at specified timepoints. Thyroid function (TSH, FT4, FT3) followed up to 5 years. Patient satisfaction via interviews, questionnaire and VAS for pain."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

17-01-2025

Processing Time Days

2

Number Of Sites

14

Number Of Participants

232

Primary sponsor

Full Name

Rijnstate Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands