Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT03013257
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of GD based on standard clinical criteria (elevated thyroid hormone levels, suppressed TSH, positive TSHR auto-antibody, diffuse goiter ± high RAI uptake).
2. Aged between 18 and 70 years old at the time of informed consent
3. Have had at least one GD relapse. A relapse is defined as recurrent or persistent hyperthyroidism despite completing a continued course of ATDs for 18 months or more.
4. Indicated for RAI treatment
5. Valid consent is obtained
Exclusion Criteria:
1. Prefer or have clear indications for surgery (such as those with large compressive goiter, suspected or documented thyroid malignancy, wishing to become pregnant within 6 months or with moderate to severe GO).
2. Have pre-existing vocal cord palsy
3. Are unable to move or extend their neck
4. Have either right, left or central (isthmic) lobe measuring \>30ml in volume on pre-treatment USG volumetry (see later)
5. Have concomitant thyroid nodules which are either indeterminate, suspicious of malignancy or proven malignant on fine needle aspiration cytology (FNAC).
6. Have active or severe Graves ophthalmopathy (GO)
7. Are pregnant, lactating or planning for pregnancy within 6 months
8. Have any medical conditions that would make them too ill to undergo intravenous sedation or treatment
9. Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03013257
Study Brief:
Protocol Section:
NCT03013257