PET-TC in Thyroid Evaluation

N/AEnrolling By InvitationNCT06852144

IRCCS Azienda Ospedaliero-Universitaria di Bologna418 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

418

Conditions

Medullary Thyroid Carcinoma Hyperparathyroidism Parathyroid Carcinoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

diagnostic performance

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

Time frame: 5 years and 6 months