18F-FDG PET/TC in TIR3A e TIR3B

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.

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Key information

Conditions

PET / CT Cytology Endocrine Gland Neoplasms Endocrine System Diseases FDG PET/CT Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna

Bologna, Italy, 40138

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical practice drug treatment

Other

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.

Primary outcomes

diagnostic performance

Time frame: 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).

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Utilizzo Della 18F-FDG PET/TC Per Stratificare il Rischio di malignità Dei Noduli Tiroidei a Citologia Indeterminata (TIR3A e TIR3B)

Acronym: PET-TIR3-2021

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2027
First posted: Feb 17, 2025
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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