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NCT03095313 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Cedars-Sinai Medical Center.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT03095313 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants.

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The verdict

NCT03095313, a Phase 2 study, has completed, sponsored by Cedars-Sinai Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

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.

Interventions

  • OTHER 18F-NaF

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-07-23
Est. Completion 2024-02-16
Phase Phase 2

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT03095313

The ClinicalTrials.gov registry entry for NCT03095313 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 18F-NaF is the first listed.

NCT03095313 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03095313 about?

NCT03095313 is a clinical study titled "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 biopro...

What is the current status of trial NCT03095313?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-07-23. Estimated completion is 2024-02-16.

What interventions are being tested in trial NCT03095313?

The interventions under investigation include: 18F-NaF (OTHER).

Who is sponsoring clinical trial NCT03095313?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.