ClinicalTrials.gg
Not yet recruitingNCT06961604Updated May 8, 2025

A Novel Method for Determination of Thromboembolic Stroke Origin

An Early Phase 1 interventional study of NaF PET-CT in Thromboembolic Stroke, sponsored by Atlantic Health System. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Atlantic Health System · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thromboembolic Stroke

Browse trials for

03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention - NaF PET

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

    Drug: NaF PET-CT

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

06

What researchers measure

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

    Time frame: Within 14 days of the stroke

Secondary outcomes

  1. Recurrent stroke

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

    Time frame: Within 1 year of imaging

  2. Management change

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

    Time frame: Within 1 year of imaging

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Jun 2025, 0 months later.

Of 71 non-industry phase 1 interventional studies under Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 0 months is below that.

Counting every sponsor, half of 97 studies reached it within 20 months; a quarter within 7 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2025
First posted
May 8, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Jun 1, 2025
CompletionEst.
May 31, 2026
Last update
May 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06961604
Lead sponsor
Atlantic Health System
Responsible party
jcassuto (MD, Atlantic Health System) — Principal investigator
First posted
May 8, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
May 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion