NCT06961604

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
1mo left

Started Jun 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jun 2025May 2026

First Submitted

Initial submission to the registry

May 6, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

May 6, 2025

Last Update Submit

May 6, 2025

Conditions

Thromboembolic Stroke

Outcome Measures

Primary Outcomes (1)

  • Culprit lesion

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

    Within 14 days of the stroke

Secondary Outcomes (2)

  • Recurrent stroke

    Within 1 year of imaging

  • Management change

    Within 1 year of imaging

Study Arms (1)

Intervention - NaF PET

EXPERIMENTAL

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

Drug: NaF PET-CT

Interventions

NaF PET-CTDRUG

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 - NaF PET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 8, 2025

Study Start

June 1, 2025

Primary Completion

June 1, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations

US(1)