NCT06906471RecruitingPhase 1
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
Antelope Surgical Solutions, Inc3 sites in 1 country10 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- Safety of AS1986NS
Study Overview
Brief Summary
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single dose of AS1986NS
Experimental
Single dose of AS1986NS administered as an injection through peripheral intravenous access.
Intervention: AS1986NS (Drug)
Outcomes
Primary Outcomes
Safety of AS1986NS
Time Frame: Enrollment to 30 days post single infusion
Demonstrate that AS1986NS is 'safe' as a microdosed \<100 µg, \<100 µL, 1 mg/mL per patient dose when introduced intravenously as a bolus through peripheral intravenous access by evaluation of the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with AS1986NS
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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