NCT07163806

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025May 2028

First Submitted

Initial submission to the registry

September 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

September 2, 2025

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT

    Assess 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.

    3 years

Interventions

PET/CT with 18-FDGDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Achury C, Estorch M, Domenech A, Camacho V, Flotats A, Jaller R, Geraldo L, Deportos J, Montes A, Carrio I. [Interpretation of thyroid incidentalomas in (18)F-FDG PET/CT studies]. Rev Esp Med Nucl Imagen Mol. 2014 Jul-Aug;33(4):205-9. doi: 10.1016/j.remn.2013.12.006. Epub 2014 Feb 21. Spanish.

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Central Study Contacts

hemat abdelsamea, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
fatma abdelzaher

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 9, 2025

Study Start

October 30, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share