Recruiting NCT06906471
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AS1986NS.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostate Cancer (Adenocarcinoma), Fluorescence Imaging. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Interventions
- Drug AS1986NS
Single dose, IV, 100 µg of AS1986NS
Primary outcome measures
- Safety of AS1986NS [Time frame: Enrollment to 30 days post single infusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- HCA Florida Kendall Hospital — Miami
- Icahn School of Medicine at Mount Sinai (ISMMS) — New York
Publications
- 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. PMID 29676909
- 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. PMID 31120734
- 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 PMID 33879400
Identifiers
NCT: NCT06906471 · 173786_007_1