An observational study in PET / CT, FDG PET/CT and Cytology, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 216 is above the median of 161 across 82 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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.
diagnostic performance
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).
Time frame: 6 years
Plan to share: Undecided
Ran from Mar 2022 to primary completion in Dec 2024, 32 months.
Of 38 observational studies under Thyroid Nodule, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32. This study's 32 months is below that.
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