Clinical trial NCT06829043: 18F-FDG PET/TC in TIR3A E TIR3B
Official title: Utilizzo Della 18F-FDG PET/TC Per Stratificare Il Rischio Di Malignità Dei Noduli Tiroidei a Citologia Indeterminata (TIR3A E TIR3B)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PET / CT
FDG PET/CT
Cytology
Thyroid Nodules
Keywords: PET/TC
cytology
18F-FDG
thyroid nodules
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study is addressed to all patients belonging to the U.O. of Nuclear Medicine of the IRCCS AOU of Bologna for execution of needle aspirate on thyroid nodules with undetermined cytology (TIR3A, TIR3B) and candidates for surgery from 1 February 2022 to 1 February 2027. These patients will be referred to 18F-FDG PET/CT survey at our Center. If the patient has already performed the 18F-FDG PET/CT survey at our Center (within 4 months of performing the needle aspiration), with guidelines, this survey will be included without repetition.

The expected duration of the scientific study (patient enrollment, data analysis, preparation of an article) is 6 years.

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.

Eligibility criteria: 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

Primary outcomes:
measure: diagnostic performance
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna
Study officials:
References:
citation: Kresnik E, Gallowitsch HJ, Mikosch P, Stettner H, Igerc I, Gomez I, Kumnig G, Lind P. Fluorine-18-fluorodeoxyglucose positron emission tomography in the preoperative assessment of thyroid nodules in an endemic goiter area. Surgery. 2003 Mar;133(3):294-9. doi: 10.1067/msy.2003.71.
citation: Abooshahab R, Gholami M, Sanoie M, Azizi F, Hedayati M. Advances in metabolomics of thyroid cancer diagnosis and metabolic regulation. Endocrine. 2019 Jul;65(1):1-14. doi: 10.1007/s12020-019-01904-1. Epub 2019 Apr 1.