18F-NaF PET Scan for Aortic Stenosis

Overseen By Daniel S. Berman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Atrial fibrillation, Paget's, Metastatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Daniel S Berman, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for people aged 60 or older who had a transcatheter or surgical bioprosthetic aortic valve replacement between 1 month and 5 years ago. It's not for those with metastatic cancer, active atrial fibrillation, severe iodine contrast allergies, Paget's disease, or high creatinine levels.

Inclusion Criteria

I had a valve replacement in my heart between 1 month and 5 years ago.

I am 60 years old or older.

Exclusion Criteria

My cancer has spread to other parts of my body.

I have an ongoing irregular heartbeat.

Your creatinine level is higher than 1.5 mg/dL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo an 18F-NaF PET scan and a contrast-enhanced CT scan

1 day

1 visit (in-person)

Year 1 Follow-up

Clinical assessment, labs, and echocardiograms are conducted

1 day

1 visit (in-person)

Year 2 Follow-up

Participants undergo a contrast-enhanced CT scan, clinical assessment, labs, and echocardiograms

1 day

1 visit (in-person)

Long-term Follow-up

Telephone contact to provide follow-up for major cardiovascular adverse events

3 years

Annual telephone contact

Treatment Details

Interventions

• 18F-NaF

Trial Overview The study tests how well an imaging technique using the tracer '18F-NaF' in PET/CT scans can show calcification activity in artificial heart valves and predict their durability based on age, type of valve, and clinical data.

Participant Groups

Group I: 18F-NaF PET and CT scanning Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+