18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified February 2022 by Cedars-Sinai Medical Center
Sponsor
Cedars-Sinai Medical Center
Information Provided by (Responsible Party)
Daniel S. Berman
Clinicaltrials.gov Identifier
NCT03095313
Other Study ID Numbers:
46429
First Submitted
March 23, 2017
First Posted
March 28, 2017
Last Update Posted
February 11, 2025
Last Verified
February 2022

ClinicalTrials.gov processed this data on February 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions.

Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.

Condition or DiseaseIntervention/Treatment
Aortic Stenosis
Other: 18F-NaF

Study Design

Study TypeInterventional
Actual Enrollment20 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeDevice Feasibility
Official Title18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Study Start DateJuly 22, 2017
Actual Primary Completion DateOctober 30, 2023
Actual Study Completion DateFebruary 15, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
18F-NaF PET and CT scanning
18F-NaF PET-CT scan (at Baseline visit only) Contrast-enhanced CT Scan (at Baseline and Year 2 only) with possible beta-blocker and nitroglycerin, if medically safe.
Other: 18F-NaF
At baseline a target dose of 125 MBq 18F-NaF will be administered intravenously to all subjects who will then undergo dual cardiac and respiratory-gated PET-CT imaging of the heart and aortic valve. 125ml of iodine-based contrast agent (iohexol \[Omnipaque™\]) will be given for the CT. Nitroglycerin will be given to increase the size of the coronary arteries and a possible dose of metoprolol may be given to control target heart rate. Repeat contrast-enhanced CT of the heart and aortic valve will be conducted at Year 2 to investigate to investigate whether 18F-NaF activity predicts progression of calcification in prosthetic valves.

Outcome Measures

Primary Outcome Measures
  1. Presence of calcification activity within the replacement valve by 18F-NaF PET-CT
    Presence of calcification activity will be determined by presence of uptake of the radiotracer, 18F-NaF, on 18F-NaF PET-CT images.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Aged ≥60 years
Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement
Exclusion Criteria
Inability to provide informed consent
Creatinine \>1.5 mg/dL
History of severe allergy to iodine contrast agents
Active atrial fibrillation
Paget's disease
Metastatic malignancy

Contacts and Locations

Sponsors and CollaboratorsCedars-Sinai Medical Center
Locations
Cedars-Sinai Medical Center | Los Angeles California, United States, 90048
Investigators
Principal Investigator: Daniel S. Berman, MD, Cedars-Sinai Medical Center