18F-NaF PET Scan for Aortic Stenosis
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.12345
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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging
Participants undergo an 18F-NaF PET scan and a contrast-enhanced CT scan
Year 1 Follow-up
Clinical assessment, labs, and echocardiograms are conducted
Year 2 Follow-up
Participants undergo a contrast-enhanced CT scan, clinical assessment, labs, and echocardiograms
Long-term Follow-up
Telephone contact to provide follow-up for major cardiovascular adverse events
What Are the Treatments Tested in This Trial?
Interventions
- 18F-NaF
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor