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Safety and Efficacy of OTL78
Sponsor: Clinton Bahler
Summary
This is a trial to assess the accuracy of an imaging agent, PSMA targeted fluorescent dye OTL78 (zopocianine), in combination with Near InfraRed (NIR) fluorescent imaging, to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing standard of care prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. This trial is intended to confirm results from previous Phase 2 dose finding studies and to support the dose selection for subsequent Phase 3 development.
Official title: Safety and Efficacy of OTL78, a PSMA-targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial Randomized Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-12
Completion Date
2027-09
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery
A single dose of 0.06 mg/kg ZOPOCIANINE used with NIR fluorescent imaging following completion of planned 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