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A Novel Method for Determination of Thromboembolic Stroke Origin

A Novel Method for Determination of Thromboembolic Stroke Origin

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06961604
Enrollment
20
Registered
2025-05-08
Start date
2025-06-01
Completion date
2026-05-31
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic Stroke

Brief summary

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.

Interventions

DRUGNaF PET-CT

Following a non-cardiogenic thromboembolic stroke, patients will undergo NaF PET-CT imaging to identify the culprit plaque and any other vulnerable plaques at high risk for rupture

Sponsors

Atlantic Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

18 years of age or older with a non-cardiogenic thromboembolic stroke in the past 14 days.

Exclusion criteria

Less than 18 years of age, any other kind of stroke, not clinically stable to undergo PET-CT

Design outcomes

Primary

MeasureTime frameDescription
Culprit lesionWithin 14 days of the strokeCan NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke identify the likely culprit plaque as a source of the stroke

Secondary

MeasureTime frameDescription
Recurrent strokeWithin 1 year of imagingCan NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke predict the location of a future non-cardiogenic thromboembolic stroke
Management changeWithin 1 year of imagingCan NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke alter patient management

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026