A Novel Method for Determination of Thromboembolic Stroke Origin

Atlantic Health System

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Thromboembolic Stroke

Treatments: Drug: NaF PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06961604

2323793-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Intervention - NaF PET

Experimental group

Description:

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

Treatment:

Drug: NaF PET-CT