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18F-NaF PET Scan for Aortic Stenosis

Phase 2

Waitlist Available

Led By Daniel S. Berman, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Aged ≥60 years

Must not have

Metastatic malignancy

Active atrial fibrillation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether there is a correlation between aortic valve calcification and degradation of bioprostheses.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to the PET/CT scan's tracer (18F-NaF) such as rash or itching at injection site. There might also be risks associated with exposure to radiation from the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have an ongoing irregular heartbeat.

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I have Paget's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-NaF PET and CT scanningExperimental Treatment1 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.

0 / 5Eligibility criteria met