Ricerc@Sapienza

Nowadays, molecular analysis is usually applied to re-stratify the risk of malignancy of thyroid nodules with indeterminate cytology readings. Its high costs impair the widespread application: currently, the molecular testing for thyroid nodules is not reimbursed by the Italian health system.
Preliminary data shows that there is an association between some sonographic features and BRAF or TERT promoter mutations.
The main aim of the study is to identify imaging features or pattern predictive of specific molecular alterations. This may be useful to: a) avoid expensive pre-operative molecular testing in nodules whose imaging features reliably predict molecular alterations and diagnosis; b) derive prognostic data from both cytology and "radiomics biopsy" and compare their prognostic performance. Finally, the results may allow to limit the application of actual molecular testing to the cases in which it has better discriminance, improving its overall cost-effectiveness.
Images will be prospectively collected from patients who undergo fine-needle aspiration biopsy with a cytological diagnosis. Each image will be de-identified, anonymized and labeled as "benign", "low-risk indeterminate", "high-risk indeterminate", or "malignant". The following data will be collected: traditional interpretation according to sonographic risk stratification system, quantitative feature extraction using radiomics and computer vision approaches. Part of cytological sample will be used to extract nucleic acids to be submitted to targeted Next-Generation Sequencing analysis. Each single human-derived sonographic feature, sonographic classification, and radiomics-derived parameter will be then evaluated to estimate its association with specific molecular alterations.
The data will demonstrate if "radiomics biopsy" would be able to reduce the number of performed cytologies, molecular testing, and thyroid surgeries, improving cost-effectiveness of the whole diagnostic algorithm.