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

NCT03095313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Stenosis

Interventions

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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Daniel S. Berman, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-23
Primary Completion
2023-10-31
Completion
2024-02-16
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095313 on ClinicalTrials.gov