Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-02 @ 4:01 AM
Study NCT ID:
NCT03015818
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-Fluoride activity', 'timeFrame': 'The day of the inclusion', 'description': '18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.'}], 'secondaryOutcomes': [{'measure': 'TBR in 18F-FDG', 'timeFrame': '6 months', 'description': 'TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process'}, {'measure': 'Both 18F-Fluoride and 18F-FDG TBR correlation', 'timeFrame': '6 months', 'description': 'Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Bioprosthesis Structural Valve Dysfunction']}, 'descriptionModule': {'briefSummary': 'Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.\n\nThis study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* written informed consent\n* SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient \\> 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Pregnancy\n* Concurrent antibiotherapy\n* Certain infectious endocarditis\n* Concurrent anti-inflammatory therapy, including corticosteroid therapy'}, 'identificationModule': {'nctId': 'NCT03015818', 'acronym': 'TEP-SVD', 'briefTitle': 'Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)', 'orgStudyIdInfo': {'id': 'RC16_0137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT', 'interventionNames': ['Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT']}], 'interventions': [{'name': '18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT', 'type': 'OTHER', 'description': '18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT', 'armGroupLabels': ['18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}