Treatment for indeterminate thyroid nodules using myo-inositol and selenium
Official title: Use of Myo-inositol and Selenium in Patients With Indeterminate Thyroid Nodules (TIR3A)
Run by Regina Elena Cancer Institute · NCT06736015 · Data updated 2026-11-12
This study is testing if a six-month treatment with a supplement of myo-inositol and selenium can help reduce the size and improve the elasticity of certain thyroid nodules in patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | October 23, 2024 |
| Main results expected | March 18, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT06736015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with thyroid nodules classified as TIR3A based on cytological evaluation.
✕Probably not a fit
Patients with diagnosed thyroid malignancies or those requiring treatment for abnormal thyroid hormone levels will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of indeterminate thyroid nodules classified as TIR3A. The study aims to determine if this treatment can reduce nodule size and cellular proliferation, assessed through ultrasound and immunocytochemistry. Participants will be randomly assigned to receive the supplement or standard care, with follow-up evaluations to assess changes in nodule characteristics. The trial is designed to provide insights into a potential non-invasive treatment option for patients with low-risk thyroid nodules.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option to reduce the size and risk of progression of indeterminate thyroid nodules.
How similar studies have gone: While there have been studies on myo-inositol and selenium for thyroid conditions, this specific approach for TIR3A nodules is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years old), * both sexes, * patients presenting thyroid nodules classified as TIR 3A, based on cytological evaluation on sample from the first fine needle aspiration (FNA), * written Informed consent, * Patients with appropriate material for subsequent immunocytochemical analysis of Ki-67 and PCNA Exclusion Criteria: * Patients with diagnosed thyroid malignancies of cytological diagnosis other than TIR3A * pathological levels of the thyroid stimulating hormone (TSH) which required L-Thyroxine treatment starting * pregnancy and/or breastfeeding
Where it's running
-
Regina Elena National Cancer Institute
Rome, Italy Recruiting
Study contacts
- Principal investigator: Marialuisa Appetecchia, MD — Regina Elena National Cancer Institute - IRCCS IFO
- Study coordinator: Marialuisa Appetecchia, MD
- Email: marialuisa.appetecchia@ifo.it
- Phone: 0039 0652666026
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.