thyroid nodules thyroid tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with thyroid nodules who underwent or will undergo an ultrasonography (with TIRADS score) with FNA if indicated and will be scheduled for a (hemi)thyroidectomy if indicated; 2. Age >= 18 years; 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric conditions that compromise the patients' ability to give informed consent; 2. Previous surgery in head and neck area on the ipsilateral side of the index nodule 3. Previous radiotherapy in head and neck area 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is quantification of the optoacoustic signal (HbO2, HbR, HbT, sO2, fat, water and collagen) observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo in patients with thyroid nodules, also in relation to the definitive pathology results (benign vs malignant). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To explore a potential correlation between endogenous optoacoustic signals in vivo with cytology (the standard-of-care of Bethesda scoring system derived from FNA) - To explore a potential correlation between endogenous optoacoustic signals in vivo with TIRADS ultrasonography scoring system (the scoring system used by radiologists when evaluating the thyroid nodules with ultrasonography). | — |
Countries
Netherlands