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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method using 18F-NaF PET scans to study aortic stenosis, a condition where the heart's aortic valve narrows and affects blood flow. The goal is to determine if this scan can track changes in the valve over time, particularly after a valve replacement. This information could aid in planning better treatments in the future. Participants over 60 who had an aortic valve replacement in the last 1 to 5 years may be a good fit. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging protocol is safe?

Research has shown that 18F-NaF PET scans are commonly used in medical imaging, particularly for heart conditions like aortic stenosis. In previous studies, patients tolerated 18F-NaF well, with no serious side effects reported. This imaging method is considered safe and noninvasive, as it doesn't require surgery or cutting into the body. Using 18F-NaF in these scans helps doctors assess the extent of calcium hardening in the heart valves, which is crucial for understanding and tracking the disease. Overall, existing evidence suggests that the 18F-NaF PET scan is a safe option for imaging heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-NaF PET scan for aortic stenosis because it offers a new way to detect calcium deposits in the heart valves, which is crucial for diagnosing and understanding the progression of this condition. Unlike traditional methods like echocardiograms or standard CT scans, 18F-NaF PET scans provide a more detailed picture of calcification activity. This can potentially allow doctors to catch aortic stenosis earlier and monitor it more effectively, leading to better treatment decisions and outcomes for patients.

What evidence suggests that the 18F-NaF PET scan is effective for assessing aortic stenosis?

Research has shown that the 18F-NaF PET scan, which participants in this trial will undergo, is promising for identifying active calcium buildup in aortic stenosis. Studies have demonstrated that 18F-NaF can detect early microcalcifications, or tiny calcium deposits, in the aortic valve. This capability helps predict disease progression. Specifically, one study found that 18F-NaF uptake can signal active tissue calcification, a key factor in the worsening of aortic stenosis over time. These findings suggest that 18F-NaF PET scans could be a powerful tool for early diagnosis and monitoring of aortic stenosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel S Berman, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9171046/

Prediction of Aortic Stenosis Progression by 18F-FDG and ...

The aim of this study was to assess prognostic value of valvular inflammation and calcification measured by 18 F-FDG and 18 F-NaF PET/CT in patients with ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/circimaging.113.001508

18F-Sodium Fluoride Uptake Is a Marker of Active ...

Conclusions—. 18F-NaF uptake identifies active tissue calcification and predicts disease progression in patients with calcific aortic stenosis.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6541558/

Analytical Quantification of Aortic Valve 18F-Sodium ...

Mean noise decreased from 11.7% in the diastolic gate to 6.7% in motion-corrected images (p=0.002); SNR increased from 25.41 to 41.13 (p=0.0001). Aortic valve ...

4.

jnm.snmjournals.org

jnm.snmjournals.org/content/65/supplement_2/241356

Advancements in Aortic Stenosis Imaging: The Emerging Role ...

18F-NaF's ability to detect early microcalcifications makes it a powerful tool for early diagnosis and prognostication of potential adverse ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03095313

NCT03095313 | 18-F Sodium Fluoride (18F-NaF) PET for ...

This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7310305/

18F-Sodium Fluoride (18F-NaF) for Imaging ...

18 F-NaF PET has been used to investigate a wide range of valvular conditions, including aortic stenosis, mitral annular calcification, and bioprosthetic valve ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03095313

18-F Sodium Fluoride (18F-NaF) PET for the Assessment ...

This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity ...

8.

ahajournals.org

ahajournals.org/doi/10.1161/circimaging.116.005131

Optimization and Reproducibility of Aortic Valve 18F- ...

18F-Fluoride positron emission tomography (PET) and computed tomography (CT) can measure disease activity and progression in aortic stenosis ...

9.

jacc.org

jacc.org/doi/10.1016/j.jcmg.2022.01.003

18 F-Sodium Fluoride Positron Emission Tomography and ...

18 F-NaF PET/CT holds promise as a noninvasive marker of disease severity and future risk in patients with acute aortic syndrome.

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1936878X18310209

The Role of Imaging in Measuring Disease Progression ...

Radiolabeled sodium fluoride (18F-NaF) is a widely available PET tracer that can be used to measure calcification activity in the vasculature, with an affinity ...