A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
Purpose
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Conditions
- Prostate Cancer
- Prostate Cancer (Adenocarcinoma)
- Fluorescence Imaging
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single dose of AS1986NS |
Single dose of AS1986NS administered as an injection through peripheral intravenous access. |
|
Recruiting Locations
HCA Florida Kendall Hospital
Miami, Florida 33175
Miami, Florida 33175
More Details
- Status
- Recruiting
- Sponsor
- Antelope Surgical Solutions, Inc