Thyroid IncidentalomasNCT07163806
Volumetric Parameter of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas
An observational study of Thyroid Incidentalomas, run by Fatma Abelzaher Mahmoud Ahmed.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thyroid Incidentalomas
- What is being tested?
- PET/CT with 18-FDG
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2025to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,
Who may be able to join
- All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,
Who cannot join
- o Known history of thyroid malignancy.
- Previous thyroid surgery .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Value of Volumetric Parameters of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas.
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.
Read the 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
- Conditions
- Thyroid Incidentalomas
- Being tested
- PET/CT with 18-FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid IncidentalomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Abelzaher Mahmoud Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Abelzaher Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163806
- Sponsor's protocol ID
- thyroid incidentaloma PET/CT
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24560597
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Volumetric Parameters of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas.
- ClinicalTrials.gov ID
- NCT07163806
- Acronym / sponsor ID
- thyroid incidentaloma PET/CT
- Conditions
- Thyroid Incidentalomas
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fatma Abelzaher Mahmoud AhmedUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,
Key inclusion criteria (1 listed)
- All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,
Key exclusion criteria (2 listed)
- o Known history of thyroid malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT with 18-FDGPatients 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 | Diagnostic test | – |
Primary outcome
Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Results publication: PubMed 24560597Achury 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Incidentalomas, run by Fatma Abelzaher Mahmoud Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hemat abdelsamea, MD (+2010053226, Hemat.ahmad2012@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.