Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06961604

A Novel Method for Determination of Thromboembolic Stroke Origin

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Thromboembolic Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location contact

James Cassuto, MD, PhD

CONTACT

[email protected]

908-522-2337

James Cassuto, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NaF PET-CT

Drug

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

Primary outcomes

  1. Culprit lesion

    Time frame: Within 14 days of the stroke

    Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke identify the likely culprit plaque as a source of the stroke

Secondary outcomes

  1. Recurrent stroke

    Time frame: Within 1 year of imaging

    Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke predict the location of a future non-cardiogenic thromboembolic stroke

  2. Management change

    Time frame: Within 1 year of imaging

    Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke alter patient management

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.