Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD) (TEP-SVD)
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|ClinicalTrials.gov Identifier: NCT03015818|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : December 19, 2018
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.
This 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.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Bioprosthesis Structural Valve Dysfunction||Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)|
|Actual Study Start Date :||January 30, 2017|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||January 30, 2020|
|Experimental: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT||
Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
- 18F-Fluoride activity [ Time Frame: The day of the inclusion ]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.
- TBR in 18F-FDG [ Time Frame: 6 months ]TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process
- Both 18F-Fluoride and 18F-FDG TBR correlation [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015818
|Contact: Nicolas PIRIOU, MCU-PH||+33 2 53 48 27 firstname.lastname@example.org|
|Nantes University Hospital||Recruiting|
|Contact: Nicolas Piriou, MCU-PH|