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Completed

NCT Number: NCT03095313

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

This is a pilot study in which we 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.

Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-NaF

Other

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.

Other names: 18F Sodium Flouride, sodium flouride PET

Primary outcomes

  1. Presence of calcification activity within the replacement valve by 18F-NaF PET-CT

    Time frame: Baseline

    Presence of calcification activity will be determined by presence of uptake of the radiotracer, 18F-NaF, on 18F-NaF PET-CT images.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Mar 29, 2017
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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