PET-TC in Thyroid Evaluation

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.

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Key information

Conditions

Medullary Thyroid Carcinoma Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperparathyroidism Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Parathyroid Carcinoma Parathyroid Diseases Parathyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna

Bologna, Bo, 38050, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

clinical practice drug treatment

Other

Observational, prospective and retrospective study, transversal, non-profit, monocentric. All data of patients affected/ afferents to theU.O. of Nuclear Medicine of the IRCCS AOU of Bologna will be collected submitted/ who will undergo a PET/ CT investigation for thyroid pathology or other indication with incidental feedback of thyroid uptake and patients who have They undergo PET/CT with known thyroid disease. Of these patients will be collected the personal data, clinical news, data related to PET/ CT (dedicated software e.g. MIM), biochemical/ laboratory and anatomopathological (for operated patients), any other imaging investigations already performed and to be performed later by normal clinical practice. The medical nuclear images will be evaluated by at least two nuclear medical experts, with qualitative, semi-quantitative and radiometric parameters as far as possible. Patients will be treated according to normal clinical practice.

Primary outcomes

diagnostic performance

Time frame: 5 years and 6 months

Sensitivity, specificity, AUC, detection rate, accuracy, positive and negative predictive value compared to the reference standard.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico

Acronym: PEPATI-MN-2024

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: Feb 28, 2025
Registry last updated: Feb 28, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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