Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-03 @ 8:27 PM
Study NCT ID:
NCT06930066
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Pediatric Liver and Spleen SWE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal liver and spleen stiffness values', 'timeFrame': 'Day 1', 'description': 'This study aims to establish reference values for liver and spleen stiffness in healthy children using shear wave elastography (SWE).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shear Wave Elastography', 'Liver Stiffness', 'Spleen Stiffness', 'Pediatric Elastography', 'Normal Reference Values', 'Organ Stiffness Measurement'], 'conditions': ['Liver Stiffness', 'Spleen Stiffness', 'Shear Wave Elastography in Healthy Children', 'Normal Organ Elasticity', 'Pediatric Elastography']}, 'descriptionModule': {'briefSummary': 'This observational study aims to determine normal liver and spleen stiffness values in healthy children using shear wave elastography (SWE). The study will include participants from the pediatric age group without known liver or spleen disease. SWE measurements will be performed non-invasively to establish reference values. The results may contribute to improving diagnostic accuracy in pediatric elastography applications.', 'detailedDescription': 'Shear wave elastography (SWE) is a non-invasive imaging method used to assess tissue stiffness. While reference values for SWE have been established in adults, data regarding normal liver and spleen stiffness in children are limited. This single-center, cross-sectional observational study aims to establish normative SWE values for the liver and spleen in the pediatric age group. Children with no known liver or spleen pathology will undergo standardized SWE measurement under controlled conditions. Age-specific and sex-specific reference ranges will be analyzed, which may contribute to enhancing the clinical utility of SWE in pediatric practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of healthy children aged 0-18 years, with no known liver or spleen pathology. These participants will be selected from pediatric clinics, specifically those who are seeking routine healthy child check-ups and have no underlying diseases. Non-invasive shear wave elastography (SWE) will be used to assess normal liver and spleen stiffness values. Participants will be selected based on inclusion criteria of being free from any liver or spleen disease, and exclusion criteria will ensure that children with known hepatic or splenic conditions are not included. Parental or guardian consent will be obtained for each participant.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children aged 0-18 years\n* No known liver or spleen pathology\n* Written informed consent obtained from parents or guardians\n\nExclusion Criteria:\n\n* Known liver disease (e.g., hepatitis, cirrhosis)\n* Known spleen disease (e.g., splenomegaly)\n* Any history of liver or spleen disease\n* Age outside the 0-18 years range'}, 'identificationModule': {'nctId': 'NCT06930066', 'acronym': 'SWE', 'briefTitle': 'Normal Pediatric Liver and Spleen SWE', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Normal Liver and Spleen Stiffness Values Using Shear Wave Elastography in Children', 'orgStudyIdInfo': {'id': '2024/522'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Children', 'description': 'This group includes healthy pediatric participants with no known liver or spleen disease. Each participant will undergo non-invasive shear wave elastography (SWE) to assess liver and spleen stiffness for the purpose of establishing normal reference values.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '42130', 'city': 'Konya', 'state': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Akif AGIR, MD', 'role': 'CONTACT', 'email': 'mehmetakif_68@hotmail.com', 'phone': '+905052910809'}], 'facility': 'Selçuk University Faculty of Medicine', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'Mehmet Akif AGIR, Medical Doctor', 'role': 'CONTACT', 'email': 'mehmetakif_68@hotmail.com', 'phone': '+905052910809'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Gastroenterologist', 'investigatorFullName': 'Mehmet Akif AĞIR', 'investigatorAffiliation': 'Selcuk University'}}}}