MedDataX Logo

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

NCT ID: NCT06906471

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Prostate Cancer (Adenocarcinoma) Fluorescence Imaging

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fluorescent agent PSMA prostate surface membrane antigen histopathology fluorescence-guided surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single dose of AS1986NS

Single dose of AS1986NS administered as an injection through peripheral intravenous access.

Group Type EXPERIMENTAL

AS1986NS

Intervention Type DRUG

Single dose, IV, 100 µg of AS1986NS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AS1986NS

Single dose, IV, 100 µg of AS1986NS

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Antelope Surgical Solutions, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HCA Florida Kendall Hospital

Miami, Florida, United States

Site Status

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States

Site Status

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amy Wu, MD

Role: CONTACT

Phone: 917-960-8876

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shirin Razdan, MD

Role: primary

Sujit Nair, PhD

Role: primary

Po-Hung Lin, MD

Role: primary

Jing-Ren Tseng, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Kommidi H, Guo H, Nurili F, Vedvyas Y, Jin MM, McClure TD, Ehdaie B, Sayman HB, Akin O, Aras O, Ting R. 18F-Positron Emitting/Trimethine Cyanine-Fluorescent Contrast for Image-Guided Prostate Cancer Management. J Med Chem. 2018 May 10;61(9):4256-4262. doi: 10.1021/acs.jmedchem.8b00240. Epub 2018 Apr 20.

Reference Type BACKGROUND
PMID: 29676909 (View on PubMed)

Guo H, Kommidi H, Vedvyas Y, McCloskey JE, Zhang W, Chen N, Nurili F, Wu AP, Sayman HB, Akin O, Rodriguez EA, Aras O, Jin MM, Ting R. A Fluorescent, [18F]-Positron-Emitting Agent for Imaging Prostate-Specific Membrane Antigen Allows Genetic Reporting in Adoptively Transferred, Genetically Modified Cells. ACS Chem Biol. 2019 Jul 19;14(7):1449-1459. doi: 10.1021/acschembio.9b00160. Epub 2019 Jun 17.

Reference Type BACKGROUND
PMID: 31120734 (View on PubMed)

Aras O, Demirdag C, Kommidi H, Guo H, Pavlova I, Aygun A, Karayel E, Pehlivanoglu H, Yeyin N, Kyprianou N, Chen N, Harmsen S, Sonmezoglu K, Lundon DJ, Oklu R, Ting R, Tewari A, Akin O, Sayman HB. Small Molecule, Multimodal, [18F]-PET and Fluorescence Imaging Agent Targeting Prostate-Specific Membrane Antigen: First-in-Human Study. Clin Genitourin Cancer. 2021 Oct;19(5):405-416. doi: 10.1016/j.clgc.2021.03.011. Epub 2021 Mar 19.

Reference Type BACKGROUND
PMID: 33879400 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

173786_007_1

Identifier Type: -

Identifier Source: org_study_id