A Novel Method for Determination of Thromboembolic Stroke Origin

NCT ID: NCT06961604

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboembolic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention - NaF PET

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

Group Type EXPERIMENTAL

NaF PET-CT

Intervention Type 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

Interventions

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NaF 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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jcassuto

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Overlook Medical Center

Summit, New Jersey, United States

Site Status

Countries

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United States

Facility Contacts

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James Cassuto, MD, PhD

Role: primary

908-522-2337

Other Identifiers

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2323793-1

Identifier Type: -

Identifier Source: org_study_id

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