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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment NaF PET-CT for stroke?

The use of PET (positron emission tomography) in cerebrovascular disease has shown potential in providing detailed measurements of brain blood flow and metabolism, which can help understand stroke pathophysiology and predict outcomes. However, PET scans have not yet been proven necessary for individual patient care decisions, and further studies are needed to confirm their impact on patient management. ^{1 2 3 4 5}

Is NaF PET-CT generally safe for humans?

The safety of NaF PET-CT specifically isn't directly addressed, but similar imaging procedures using contrast agents are generally safe, with low risk of side effects. It's important for clinicians to minimize risks and respond quickly if reactions occur. ^{6 7 8 9 10}

How does NaF PET-CT treatment differ from other stroke treatments?

NaF PET-CT is unique because it uses a special imaging technique to detect microcalcification activity in the brain, which can indicate acute cell death during a stroke. This approach is different from standard stroke treatments, which typically focus on restoring blood flow or preventing further clotting, rather than imaging and assessing tissue changes. ^{11 12 13 14 15}

What is the purpose of this trial?

Rupture of vulnerable carotid, vertebral, and intracranial arterial plaques results in thromboembolic stroke. Identification of these culprit lesions is an important component of post-stroke care. 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 between NaF PET+ lesions and high-risk plaque features on high resolution MRI, including mirocalcification, necrosis, and ulceration.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Early outcome after intravenous thrombolysis in patients with acute ischemic stroke. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Perfusion computed tomography in prediction of functional outcome in patients with acute ischaemic stroke. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Correlation of functional independence measure (FIM) and SPECT Iofetamine (I-123) as a predictor of functional return in stroke. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Timing of neurological improvement after acute ischemic stroke and functional outcome. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The use of positron emission tomography in cerebrovascular disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of performing CT angiography in stroke patients treated with intravenous thrombolysis. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Functional contrast-enhanced CT for evaluation of acute ischemic stroke does not increase the risk of contrast-induced nephropathy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Intravenous Imaging Contrast Media Complications: The Basics That Every Clinician Needs to Know. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Sodium [¹⁸F]fluoride PET/CT in myocardial infarction. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The uptake pattern of 18F-sodium fluoride radioligand in brain tissue after cerebral infarction. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Stroke detection with 3 different PET tracers. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

In&#160;Vivo Coronary 18F-Sodium Fluoride&#160;Activity: Correlations With Coronary Plaque Histological Vulnerability and Physiological Environment. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Evaluation of neck pain with (18)F-NaF PET/CT. [2016]