Clinical trial · Observational
18F-FDG PET/TC in TIR3A e TIR3B
Utilizzo Della 18F-FDG PET/TC Per Stratificare il Rischio di malignità Dei Noduli Tiroidei a Citologia Indeterminata (TIR3A e TIR3B)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytology | — | UNRESOLVED | — |
| FDG PET/CT | — | UNRESOLVED | — |
| PET / CT | — | UNRESOLVED | — |
| Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical practice drug treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TIR3 group
- description
- 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.
- interventionNames
- Other: clinical practice drug treatment
Primary outcomes (1)
- measure
- diagnostic performance
- timeFrame
- 6 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTKresnik 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. PMID 12660642
- RESULTAbooshahab 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. PMID 30937722