An observational study in Medullary Thyroid Carcinoma, Hyperparathyroidism and Parathyroid Carcinoma, 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 2025-02-28.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
144 studies on the registry are indexed under Carcinoma, Medullary; 30 are open to participants now.
This study's planned enrollment of 418 is above the median of 155 across 31 observational studies indexed under Carcinoma, Medullary.
Browse Carcinoma, Medullary 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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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.
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For the retrospective part:
For the prospective part:
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.
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.
Other: clinical practice drug treatment
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.
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
Plan to share: Undecided
Started Oct 2024 (actual). Primary completion is estimated for Apr 2029, 54 months after the start.
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