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

Phase 2Not Yet RecruitingNCT06906471

Antelope Surgical Solutions, Inc10 enrolled

Overview

A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer Prostate Cancer (Adenocarcinoma)Fluorescence Imaging

Interventions

AS1986NSDRUG

Single dose, IV, 100 µg of AS1986NS

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

HCA Florida Kendall Hospital

Miami, Florida, United States

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan

Outcomes

Primary Outcomes

Safety of AS1986NS

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

Time frame: Enrollment to 30 days post single infusion

Central Contacts

Amy Wu, MD

CONTACT

917-960-8876 info@antelopesurgical.com

Data from ClinicalTrials.gov

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