NaF PET-CT for Stroke

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Atlantic Health System

Disqualifiers: Under 18, Other stroke types, Unstable, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special scan called NaF PET-CT (a type of imaging test) can detect dangerous plaques in blood vessels that might cause strokes. The goal is to determine if this scan can help doctors improve care for people after a stroke by identifying these risky areas in their arteries. Individuals who have experienced a non-cardiac-related stroke in the past two weeks may qualify for this study. As an Early Phase 1 trial, this research aims to understand how the scan functions in people, providing an opportunity to contribute to groundbreaking medical advancements.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that NaF PET-CT is safe for detecting arterial plaques?

Research has shown that NaF PET-CT, which uses a tracer called 18F-NaF, has been studied for other health issues like heart valve problems and plaque buildup in arteries. These studies generally found the procedure to be safe. For instance, one study found that even with a much lower dose of 18F-NaF, safety remained unchanged, indicating it is well-tolerated.

However, using NaF PET-CT specifically to detect stroke-related plaque remains in the early research stages. While the results are promising, direct safety data for this specific use is not yet available. This means that although the procedure is being tested for safety, it hasn't been fully confirmed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NaF PET-CT is unique because it offers a new way to visualize and understand stroke-related damage in the brain. Unlike standard imaging techniques like MRI or CT scans, NaF PET-CT specifically highlights areas in the brain where calcium deposits are forming, which are often linked to stroke. Researchers are excited about this technique because it could provide more precise information about the extent and location of strokes, potentially leading to better-targeted treatments and improved outcomes for patients.

What evidence suggests that NaF PET-CT is effective for detecting plaques in stroke patients?

Research has shown that NaF PET-CT scans can identify dangerous buildups in blood vessels that might lead to strokes. Studies have found a strong connection between areas that light up on these scans and risky plaque features, such as small calcium deposits, dead tissue, and ulcers. NaF PET-CT distinguishes between symptomatic and asymptomatic plaques by assessing calcium content. This suggests it might better identify high-risk plaques than other imaging methods. Early evidence indicates that NaF PET-CT could help doctors find and treat these dangerous plaques, potentially improving stroke care. Participants in this trial will undergo NaF PET-CT to evaluate its effectiveness in identifying high-risk plaques in non-cardiogenic thromboembolic stroke patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who have had a non-cardiogenic thromboembolic stroke within the last two weeks. Participants must be stable enough to undergo PET-CT imaging. It's not open to those under 18 or anyone with a history of other types of strokes.

Inclusion Criteria

I am 18 or older and had a stroke not caused by heart issues within the last 14 days.

Exclusion Criteria

I am under 18 years old.

I am not stable enough for a PET-CT scan.

I have had a stroke before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo NaF PET-CT to detect plaques within 14 days of a non-cardiogenic thromboembolic stroke

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for recurrent stroke and management changes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• NaF PET-CT

Trial Overview The study is testing NaF PET-CT scans to see if they can find risky plaques in arteries that could cause strokes by breaking off and blocking blood flow. The goal is to improve post-stroke treatment by identifying these dangerous areas.

How Is the Trial Designed?

Group I: Intervention - NaF PET Experimental Treatment 1 Intervention

Intervention/Experimental Arm - non-cardiogenic thromboembolic stroke patients to undergo NaF PET-CT

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Published Research Related to This Trial

Intravenous contrast agents, used in imaging procedures like MRI and CT scans, have a low incidence of adverse events, but clinicians must be prepared to manage reactions effectively.

The review highlights various potential adverse events associated with iodinated and gadolinium-based contrast agents, including allergic reactions and nephrotoxicity, emphasizing the importance of risk assessment and premedication strategies for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Imaging Contrast Media Complications: The Basics That Every Clinician Needs to Know. Rose, TA., Choi, JW.[2022]

Positron emission tomography (PET) can be useful in detecting strokes incidentally during oncological imaging, as shown by focal uptakes of 11C-Choline and 68Ga-DOTATATE in areas of confirmed ischemia.

In some cases, increased 18F-FDG activity was observed around hemorrhagic regions, suggesting that PET can provide valuable insights into the flow dynamics and metabolic activity associated with stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke detection with 3 different PET tracers. Dundar, A., Bold, MS., Agac, B., et al.[2020]

In a study of 918 patients with acute ischemic stroke, those who received iodinated contrast agents during CT imaging had a lower incidence of acute nephropathy (AN) at 5% compared to 10% in those who did not receive contrast, suggesting that contrast use may not be as risky as previously thought.

Patients who underwent conventional angiography after contrast-enhanced CT did not show a higher risk of acute nephropathy compared to those who only had the CT imaging, indicating that the use of contrast in these procedures is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional contrast-enhanced CT for evaluation of acute ischemic stroke does not increase the risk of contrast-induced nephropathy. Lima, FO., Lev, MH., Levy, RA., et al.[2021]

Gadolinium-based contrast agents (GBCAs) are generally very safe for use in MRI, with acute allergic reactions being rare and less common than those associated with iodinated contrast agents.

While there are concerns about gadolinium deposition in the brain and other organs, current evidence shows no adverse biological or clinical effects from this retention, especially in patients with normal kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. Starekova, J., Pirasteh, A., Reeder, SB.[2023]

Citations

1. withpower.com withpower.com/trial/early-phase-1-stroke-5-2025-9c43a

NaF PET-CT for Stroke · Info for Participants This study seeks to test the feasibility of NaF PET-CT to detect these plaques and alter patient care. Prior studies have shown a high degree of correlation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11804149/

18F-NaF uptake on vascular PET imaging in symptomatic ... PET imaging using 18 F-NaF can detect differences in microcalcification between symptomatic and asymptomatic atherosclerotic plaques within, but not between, ...

3. nature.com nature.com/articles/s41598-022-26992-4

The uptake pattern of 18F-sodium fluoride radioligand in ... When NaF PET was applied to stroke patients, NaF radioligand was localized in the brain parenchyma where acute ischemic cell death was prevalent ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-00404

Comparing an Investigational Scan (F-18 NaF PET/CT) to ... Imaging with F-18 NaF PET/CT may be as effective or more effective than the standard F-18 FDG PET/CT for assessing the effects radiation therapy has on blood ...

5. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.121.316075

Analysis of 18F-Sodium Fluoride Positron Emission ... 18 F-sodium fluoride ( 18 F-NaF) positron emission tomography (PET) imaging is thought to visualize active atherosclerotic plaque calcification.

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. mdpi.com mdpi.com/2313-433X/9/2/31

NaF-PET Imaging of Atherosclerosis Burden Carotid artery molecular calcification assessed by [18F]fluoride PET/CT: Correlation with cardiovascular and thromboembolic risk factors.

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.725118/full

[ 18 F] Sodium Fluoride Dose Reduction Enabled by Digital ... This study demonstrated that a 60-fold [ 18 F]NaF dose reduction was not significantly different from the highest dose, and it had not significant effect on ...

9. auntminnie.com auntminnie.com/clinical-news/molecular-imaging/article/15630421/nafpet-scans-reveal-plaque-and-possible-risk-of-stroke

NaF-PET scans reveal plaque -- and possible risk of stroke PET/CT scans can show plaque development in atherosclerosis patients and may help predict which patients are at higher risk of stroke, according to a study.