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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

501 Previous Clinical Trials

164,873 Total Patients Enrolled

Daniel S. Berman, MD5.02 ReviewsPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

1 Previous Clinical Trials

55 Total Patients Enrolled

Media Library

18F-NaF Clinical Trial Eligibility Overview. Trial Name: NCT03095313 — Phase 2

Aortic Stenosis Research Study Groups: 18F-NaF PET and CT scanning

Aortic Stenosis Clinical Trial 2023: 18F-NaF Highlights & Side Effects. Trial Name: NCT03095313 — Phase 2

18F-NaF 2023 Treatment Timeline for Medical Study. Trial Name: NCT03095313 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a risk to patients when using 18F-NaF?

"Given that this is a Phase 2 trial - meaning while there is safety data, none supports efficacy - our team has rated 18F-NaF as a 2."

Answered by AI

Are there any current vacancies for this clinical trial?

"According to the information available on clinicaltrials.gov, this study is not recruiting at this time. This trial was originally posted on July 23rd, 2017 and has had 3 updates since then, with the most recent being on March 7th, 2022. There are plenty of other options for patients looking for trials as there are 164 open studies recruiting right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Daniel S. Berman 2017. "18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03095313.

All > Aortic Stenosis