18F-FDG PET/TC in TIR3A e TIR3B

Condition(s) studied

Investigational drug(s) / intervention(s)

clinical practice drug treatment: The study is observational, non-interventional and involves the review of the investigation18F-FDGPET/TC (performed according to the EANM guidelines) by two experts from the Nuclear Medicine Department.

Study summary

The primary objective of this study is to evaluate the diagnostic performance of 18F-FDG PET/CT performed by normal care pathway in the identification of malignancy of undetermined resulting thyroid lesions at cytology (TIR3A and TIR3B) comparing the 18F-FDG PET/CT result with histological data.

The secondary objective is to identify possible PET/ultrasound/genetic/radiomics variables that can more accurately define the potential malignancy of undetermined nodules and create a predictive model of malignity fed by standard parameters (derived from the normal care path).

The identification of the prognostic value of 18F-FDG PET/CT in such patients setting could, in fact, make the PET useful in the future in the selection of patients for surgery/ follow-up.

Eligibility

Primary outcome measure(s)

• diagnostic performance — 6 years
  the diagnostic capacity of 18F-FDG PET/CT evaluated by calculating the percentages of true positives, false positives, true negatives and false negatives through comparison between the histological data (positivity or negativity for neoplasm) with the 18F-FDG PET/CT (positivity or negativity to PET/CT images).

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy