Clinical trial NCT06852144: PET-TC in Thyroid Evaluation
Official title: Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Medullary Thyroid Carcinoma
Hyperparathyroidism
Parathyroid Carcinoma
Keywords: PET/TC
18F/FDG
hyperparathyroidism
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 418
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: Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months.

Brief summary: The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.

It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.

The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.

Detailed description: The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.

Eligibility criteria: Inclusion Criteria:

For the retrospective part:

* Patients aged \>18 years,
* Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
* Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
* Obtaining informed consent

For the prospective part:

* Patients aged \>18 years,
* Finding hypercaptant findings of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice.
* Patients scheduled for agesult to be no more than 12 months.
* Obtaining informed consent

Exclusion Criteria:

* Nothing

Primary outcomes:
measure: diagnostic performance
timeFrame: 5 years and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna
state: Bo
Study officials:
References:
citation: Cocchiara G, Fazzotta S, Palumbo VD, Damiano G, Cajozzo M, Maione C, Buscemi S, Spinelli G, Ficarella S, Maffongelli A, Caternicchia F, Ignazio Lo Monte A, Buscemi G. The medical and surgical treatment in secondary and tertiary hyperparathyroidism. Review. Clin Ter. 2017 Mar-Apr;168(2):e158-e167. doi: 10.7417/CT.2017.1999.
citation: Bertagna F, Albano D, Giovanella L, Giubbini R, Treglia G. F18-choline/C11-choline PET/CT thyroid incidentalomas. Endocrine. 2019 May;64(2):203-208. doi: 10.1007/s12020-019-01841-z. Epub 2019 Jan 12.
citation: Marcus C, Whitworth PW, Surasi DS, Pai SI, Subramaniam RM. PET/CT in the management of thyroid cancers. AJR Am J Roentgenol. 2014 Jun;202(6):1316-29. doi: 10.2214/AJR.13.11673.