PET-TC in Thyroid Evaluation

NCT06852144 | Enrolling By Invitation

• 2 other identifiers: PEPATI-MN-2024322/2024/Oss/AOUBo
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Thyroid Carcinoma; Hyperparathyroidism; Parathyroid Carcinoma

Keywords

PET/TC; 18F/FDG; hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• diagnostic performance

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

  5 years and 6 months

Study Arms (1)

pepati group

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

Interventions

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.

pepati group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Nothing

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna

Bologna, Bo, 38050, Italy

Location

Related Publications (3)

• 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.

  PMID: 28383630 BACKGROUND

• 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.

  PMID: 30637562 RESULT

• 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.

  PMID: 24848831 RESULT

MeSH Terms

Conditions

Carcinoma, Medullary; Hyperparathyroidism; Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 28, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 28, 2025

Record last verified: 2024-12

Locations

IT (1)