Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05238805
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2022-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will have to perform 2 scans one after the other'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean in left ventricule myocradial blood flow', 'timeFrame': '30 minutes', 'description': 'Heart acetate metabolism measured by TEP scan'}, {'measure': 'Mean in left ventricule myocardial blood flow', 'timeFrame': '30 minutes', 'description': 'Heart acetoacetate metabolism measured by TEP scan'}, {'measure': 'Mean in Kidney acetate uptake', 'timeFrame': '30 minutes', 'description': 'Kidney acetate uptake measured by TEP scan'}, {'measure': 'Mean in Kidney acetoacetate uptake', 'timeFrame': '30 minutes', 'description': 'Kidney acetoacetate uptake measured by TEP scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketones', 'heart metabolism', 'kidney metabolism'], 'conditions': ['Ketoses, Metabolic']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism', 'detailedDescription': 'Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 55\n* BMI between 18,5 and 28\n* Healthy\n* Normal value for blood pressure\n\nExclusion Criteria:\n\n* Taking drugs that could influence metabolism\n* Diabetes or prediabetes\n* Pregnancy or lactation\n* Participation in a intensive sport program\n* Being on a ketogenic diet\n* Any clinical abnomally in prescreen blood sample'}, 'identificationModule': {'nctId': 'NCT05238805', 'briefTitle': 'Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and', 'orgStudyIdInfo': {'id': '2022-4540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Observational heart and kidney metabolism', 'description': 'Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day.', 'interventionNames': ['Radiation: Observational heart and kidney on siemens TEP scan']}], 'interventions': [{'name': 'Observational heart and kidney on siemens TEP scan', 'type': 'RADIATION', 'description': 'Same as arm description', 'armGroupLabels': ['Observational heart and kidney metabolism']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Center on Aging', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestlé Health Science Spain', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}