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NaF PET-CT

Phase 1

Thromboembolic Stroke | Small molecule | Neurology |Atlantic International Corp.|Last Updated: May 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06961604A Novel Method for Determination of Thromboembolic Stroke OriginEARLY_PHASE1 NOT YET_RECRUITING 20Jun 1, 2025May 31, 2026May 8, 20251 United States
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Study Endpoints
Primary Endpoints
Culprit lesion
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 Endpoints
Recurrent stroke
Within 1 year of imaging
Management change
Within 1 year of imaging
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Intervention - NaF PETEXPERIMENTALIntervention/Experimental Arm - non-cardiogenic thromboembolic stroke patients to undergo NaF PET-CT
Interventions
NameTypeDescription
NaF PET-CTDRUGFollowing 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
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06961604studyFirstPostDate: changed