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

NCT03095313 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: 46429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transcatheter Aortic Valve Replacement (TAVR).; Surgical bioprosthetic aortic valve replacement

Outcome Measures

Primary Outcomes (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.

  Baseline

Study Arms (1)

18F-NaF PET and CT scanning

EXPERIMENTAL

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

Interventions

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.

Also known as: 18F Sodium Flouride, sodium flouride PET

18F-NaF PET and CT scanning

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥60 years
• Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Daniel S. Berman, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 29, 2017
• Study Start: July 23, 2017
• Primary Completion: October 31, 2023
• Study Completion: February 16, 2024
• Last Updated: February 12, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)