Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07725523
PHASE2/PHASE3

Phase IIb Trial to Investigate the Safety and Efficacy of OTL78 Injection (Zopocianine)

Sponsor: Clinton Bahler

View on ClinicalTrials.gov

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

DRUG

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