Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:32 AM
Study NCT ID:
NCT07163806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Parameter of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT', 'timeFrame': '3 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Incidentalomas']}, 'referencesModule': {'references': [{'pmid': '24560597', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nGlobally, 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.\n\nPrevious 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).\n\nFurthermore, 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.\n\nIn 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,\n\nExclusion Criteria:\n\n* o Known history of thyroid malignancy.\n\n * Previous thyroid surgery .'}, 'identificationModule': {'nctId': 'NCT07163806', 'briefTitle': 'Volumetric Parameter of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Value of Volumetric Parameters of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas.', 'orgStudyIdInfo': {'id': 'thyroid incidentaloma PET/CT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/CT with 18-FDG', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nThe 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'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'hemat abdelsamea, MD', 'role': 'CONTACT', 'email': 'Hemat.ahmad2012@aun.edu.eg', 'phone': '+2010053226'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatma Abelzaher Mahmoud Ahmed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'fatma abdelzaher', 'investigatorFullName': 'Fatma Abelzaher Mahmoud Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}