18F-FDG PET/TC in TIR3A E TIR3B

• Conditions: PET / CT; FDG PET/CT; Cytology; Thyroid Nodules

• Registration Number: NCT06829043
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Detailed Description

To better stratify the malignancy risk of the resulting undetermined cytological lesions (TIR3A and TIR3B), it is proposed to perform an 18F-FDG PET/TC survey in these patients by which semiquantitative parameters are derived (SUVmax, SUVmean, SUVpeak, MTV, TLG) and perform radiomatic analysis. In the case where the above mentioned PET/CT survey has been recently performed, the survey will not be repeated but the images will be reviewed with visual and semi-quantitative analysis. The results will be compared with those derived from ultrasound and genetic analysis (currently proposed in cases of TIR3A), with the subsequent histological examination derived from surgery (currently indicated by the normal care path in TIR3B cases and in case of reconfirmation of TIR3A cytology to a second needle aspiration on the nodule). It is expected that an algorithm with multiple parameters combined can be created to correctly point towards surgery or a conservative attitude of follow up.

Study Timeline

• Study Start: 2022-03-22
• Status Verified: 2024-12
• Primary Completion: 2024-12-12
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Patients with undetermined cytology (TIR3B and TIR3A candidates for surgery) and 18F-FDG PET/CT;
• Obtaining informed consent for data collection and processing.
• Patient aged 18 years

Exclusion Criteria

• Pregnant/breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna; 🇮🇹 Bologna, Italy