18F-FDG PET/TC in TIR3A E TIR3B

NCT06829043 | Enrolling By Invitation

• 1 other identifier: 50/2022/Oss/AOUBo
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the diagnostic performance of 18F-FDG PET/CT performed by normal care pathway in the identification of malignancy of undetermined resulting thyroid lesions at cytology (TIR3A and TIR3B) comparing the 18F-FDG PET/CT result with histological data. The secondary objective is to identify possible PET/ultrasound/genetic/radiomics variables that can more accurately define the potential malignancy of undetermined nodules and create a predictive model of malignity fed by standard parameters (derived from the normal care path). The identification of the prognostic value of 18F-FDG PET/CT in such patients setting could, in fact, make the PET useful in the future in the selection of patients for surgery/ follow-up.

Conditions

PET / CT; FDG PET/CT; Cytology; Thyroid Nodules

Keywords

PET/TC; cytology; 18F-FDG; thyroid nodules

Outcome Measures

Primary Outcomes (1)

• diagnostic performance

  the diagnostic capacity of 18F-FDG PET/CT evaluated by calculating the percentages of true positives, false positives, true negatives and false negatives through comparison between the histological data (positivity or negativity for neoplasm) with the 18F-FDG PET/CT (positivity or negativity to PET/CT images).

  6 years

Study Arms (1)

TIR3 group

The study is addressed to all patients belonging to the U.O. of Nuclear Medicine of the IRCCS AOU of Bologna for execution of needle aspirate on thyroid nodules with undetermined cytology (TIR3A, TIR3B) and candidates for surgery from 1 February 2022 to 1 February 2027. These patients will be referred to 18F-FDG PET/CT survey at our Center. If the patient has already performed the 18F-FDG PET/CT survey at our Center (within 4 months of performing the needle aspiration), with guidelines, this survey will be included without repetition.

Other: clinical practice drug treatment

Interventions

clinical practice drug treatment OTHER

The study is observational, non-interventional and involves the review of the investigation18F-FDGPET/TC (performed according to the EANM guidelines) by two experts from the Nuclear Medicine Department.

TIR3 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

The study is addressed to all patients belonging to the U.O. of Nuclear Medicine of the IRCCS AOU of Bologna for execution of needle aspirate on thyroid nodules with undetermined cytology (TIR3A, TIR3B) and candidates for surgery from 1 February 2022 to 1 February 2027. These patients will be referred to 18F-FDG PET/CT survey at our Center. If the patient has already performed the 18F-FDG PET/CT survey at our Center (within 4 months of performing the needle aspiration), with guidelines, this survey will be included without repetition. The expected duration of the scientific study (patient enrollment, data analysis, preparation of an article) is 6 years.

You may qualify if:

• Patients with undetermined cytology (TIR3B and TIR3A candidates for surgery) and 18F-FDG PET/CT;
• Obtaining informed consent for data collection and processing.
• Patient aged 18 years

You may not qualify if:

• \- Pregnant/breastfeeding women

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna

Bologna, Italy, 40138, Italy

Location

Related Publications (2)

• Kresnik E, Gallowitsch HJ, Mikosch P, Stettner H, Igerc I, Gomez I, Kumnig G, Lind P. Fluorine-18-fluorodeoxyglucose positron emission tomography in the preoperative assessment of thyroid nodules in an endemic goiter area. Surgery. 2003 Mar;133(3):294-9. doi: 10.1067/msy.2003.71.

  PMID: 12660642 BACKGROUND

• Abooshahab R, Gholami M, Sanoie M, Azizi F, Hedayati M. Advances in metabolomics of thyroid cancer diagnosis and metabolic regulation. Endocrine. 2019 Jul;65(1):1-14. doi: 10.1007/s12020-019-01904-1. Epub 2019 Apr 1.

  PMID: 30937722 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

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 17, 2025
• Study Start: March 22, 2022
• Primary Completion: December 12, 2024
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 17, 2025

Record last verified: 2024-12

Locations

IT (1)