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Volumetric Parameter of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas

Diagnostic Value of Volumetric Parameters of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07163806
Enrollment
88
Registered
2025-09-09
Start date
2025-10-30
Completion date
2028-05-30
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Incidentalomas

Brief summary

To assess the clinical significance of FDG-avid thyroid incidentalomas detected on PET/CT and explore correlations between SUV max, ultrasound characteristics, and histopathology for suspicious lesion.

Detailed description

Thyroid incidentalomas are unsuspected thyroid lesions discovered during imaging performed for unrelated medical reasons. With the expanding use of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for cancer staging and follow-up, the detection of incidental thyroid nodules particularly those showing focal FDG uptake-has significantly increased (Are C et al., 2007; Kim TY et al.,2005). Although the overall prevalence of thyroid incidentalomas detected on PET/CT is relatively low (reported between 1.1% and 4%), the risk of malignancy among FDG-avid nodules is high, ranging from 26.7% to 64.6%, which is considerably greater than in non-FDG-avid nodules (Shi H et al.,2018; Makis W & Ciarallo A, 2017;Choi JY et al., 2006). Globally, thyroid cancer is one of the most common endocrine malignancies, with an increasing incidence rate over the past two decades (Sung H et al.,2021). In Egypt, recent data indicate that thyroid cancer accounts for approximately 2.6% of all new cancers, with a noticeable increase in detection largely attributed to the rise in imaging investigations (Ibrahim AS et al., 2014;GLOBOCAN, 2020). Despite this increase, clinical guidelines still lack aconsensus on how to best manage thyroid incidentalomas detected by PET/CT, especially in resource-limited settings. Previous studies have explored various semi-quantitative PET parameters, particularly SUVmax, as potential indicators of malignancy. Malignant thyroid incidentalomas tend to show significantly higher SUVmax values than benign ones, but considerable overlap exists, limiting its standalone diagnostic value (Shi H et al., 2018; Kim BH et al., 2013). Furthermore, integrating ultrasound characteristics such as microcalcifications, hypoechogenicity, irregular margins, and taller-than-wide shape, has shown promise in enhancing diagnostic accuracy (Haugen BR etal., 2016; Russ G et al., 2017). However, data on how well these PET/CT and ultrasound features correlate with final histopathology remain limited in Egypt and other low-resource settings. In a large meta-analysis, the pooled risk of malignancy in FDG-avid thyroid incidentalomas was estimated at 34.6% (Bertagna F et al., 2012), but single-center studies report wide variability, which may be due to differences in patient selection, imaging thresholds, and follow-up protocols. Given the growing detection of FDG-avid thyroid nodules and the lack of clear, standardized management protocols in Egypt, there is a critical need for localized research to guide decision-making and reduce unnecessary surgeries or missed malignancies

Interventions

DIAGNOSTIC_TESTPET/CT with 18-FDG

Patients will fast for at least four hours before imaging with blood glucose level \<200 mg /dL before intravenous administration of about 3.7 MBq/kg (0.1 mCi/kg). Imaging will be performed approximately 45 to 60 min after 18F-FDG injection , an imaging field of view from the base of skull to mid thighs with the arms above the head whenever possible is used or otherwise the arms are positioned beside the body. The semiquantitative analysis will be done using standardized uptake values (SUV). The SUV calculation will be done via the default method by body weight \[(SUV = mean ROI activity (MBq/g)/injected activity (MBq)/body weight (g)\]. For measurement of SUVs of lesion, multiple circular ROIs will be drawn covering the lesion over its entire length. For healthy organs, a circular ROI of 10 mm diameter will be drawn

Sponsors

Fatma Abelzaher Mahmoud Ahmed
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

* All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,

Exclusion criteria

* o Known history of thyroid malignancy. * Previous thyroid surgery .

Design outcomes

Primary

MeasureTime frameDescription
Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT3 yearsAssess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT and explore correlations between SUVmax, TIRAD system on ultrasound, and final histopathology for suspicious lesion.

Contacts

Primary Contacthemat abdelsamea, MD
Hemat.ahmad2012@aun.edu.eg+2010053226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026