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Phase IIb Trial to Investigate the Safety and Efficacy of OTL78 Injection (Zopocianine)
Sponsor: Clinton Bahler
Summary
This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Official title: Safety and Efficacy of OTL78 (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-09
Completion Date
2027-04
Last Updated
2026-07-24
Healthy Volunteers
No
Interventions
0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
Locations (2)
Indiana University Health North Hospital
Carmel, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States