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NCT06736015Recruiting

Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)

Use of Myo-inositol and Selenium in Patients With Indeterminate Thyroid Nodules (TIR3A)

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

Thyroid nodules present a variable risk of malignancy depending on the cytological result obtained from the ultrasound-assisted thyroid fine needle aspiration biopsy. According to the Italian Cytology classification SIAPEC-IAP 2014, the TIR3A nodules are indeterminate nodules with a risk of malignancy lower than 10%. Clinical and instrumental follow-up is recommended in these cases, including repetition of the fine needle aspiration. A study have demonstrate the effect of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of benign thyroid nodules. Our hypothesis is that the use of this supplement can determine a reduction in the size and consistency of the nodule assessed through ultrasound and elastosonography also in cytologically indeterminate (TIR3A) nodules and that treatment can reduce the cellular proliferation of these nodules assessed by immunocytochemistry. Therefore, we design a prospective randomized pilot study to assess efficacy and safety of myo-inositol and selenium in TIR3a thyroid nosules, comparing treated and untreated patients.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
5 Dec 2024
Start date
23 Oct 2024
Primary completion date
18 Mar 2027
Lead sponsor
Regina Elena Cancer Institute
NCT number
NCT06736015

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 23 Oct 2024 to the primary completion date, 18 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with diagnosed thyroid malignancies of cytological diagnosis other than TIR3A

Other

  • pathological levels of the thyroid stimulating hormone (TSH) which required L-Thyroxine treatment starting
  • pregnancy and/or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Regina Elena National Cancer Institute
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.