Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT06626932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implications of Biological and Procedural Factors of 18-f FDG Uptake by Normal Organs and Neoplastic Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 259}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET/CT scan on cancer patient will be performed to evaluate the biological and procedural factors of 18-f FDG uptake by multiple normal organs and neoplastic lesions using Standardized uptake values', 'timeFrame': '2 years', 'description': 'SUV mean , suv peak and suv max'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18-f FDG PET/CT'], 'conditions': ['Oncologic Diseases']}, 'descriptionModule': {'briefSummary': 'To evaluate implications of biological and procedural factors of 18-f FDG PET/CT uptake on normal organs and neoplastic lesions.', 'detailedDescription': '18-f FDG is used on oncological patients undergoing PET/CT study at our nuclear medicine unit , its uptake by the tissues depends on glucose blood level and consumption then we evaluate the implications of biological and procedural factors on the uptake by normal organs and neoplastic lesions using standardized uptake values SUVmax , mean and peak.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cancer patients referred to nuclear medicine unit\n\nExclusion Criteria:\n\n* patients with increased FDG uptake associated with non malignant causes such as diffuse bone marrow FDG uptake or lung infection or patients with extensive metastasis in target organs'}, 'identificationModule': {'nctId': 'NCT06626932', 'briefTitle': 'Implications of Biological and Procedural Factors of 18-f FDG Uptake by Normal Organs and Neoplastic Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Implications of Biological and Procedural Factors of 18-f FDG PET/CT Uptake by Normal Organs and Neoplastic Lesions', 'orgStudyIdInfo': {'id': '18-FDG PET/CT scan'}}, 'armsInterventionsModule': {'interventions': [{'name': '18 FDG (Fludeoxyglucose 18F)', 'type': 'RADIATION', 'description': '18-f FDG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mahenoor Alaa Abouelouon, Master', 'role': 'CONTACT', 'email': 'mahyswifty@gmail.com', 'phone': '201000488247'}, {'name': 'nadia mohany mostafa, assistant professor', 'role': 'CONTACT', 'email': 'drnadia1980@gmail.com', 'phone': '01125006468'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mahenoor alaa eldeen naem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'mahenoor alaa eldeen naem', 'investigatorAffiliation': 'Assiut University'}}}}