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Recruiting

A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS

NCT06906471 · Antelope Surgical Solutions, Inc
In plain English

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About this study
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Eligibility criteria
Inclusion Criteria: * suspected prostate cancer warranting standard of care multi-core prostate biopsy Exclusion Criteria: * Patients receiving same-day therapeutic Lutetium-177 or Actinium-225 PSMA receptor radiation isotope therapy treatment * Patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature * Patients with a creatinine clearance cutoff (CrCl) of \< 60 mL/min
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-01
Estimated completion: 2026-12-30
Last updated: 2026-07-09
Interventions
Drug: AS1986NS
Primary outcomes
  • Safety of AS1986NS (Enrollment to 30 days post single infusion)
Sponsor
Antelope Surgical Solutions, Inc · industry
Contacts & investigators
ContactAmy Wu, MD · contact · info@antelopesurgical.com · 917-960-8876
All locations (2)
HCA Florida Kendall HospitalRecruiting
Miami, Florida, United States
Icahn School of Medicine at Mount Sinai (ISMMS)Not Yet Recruiting
New York, New York, United States
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS · TrialPath