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Safety and Efficacy of OTL78 (Zopocianine)

NCT07725523 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Surgery
  • Prostate Cancer Metastatic Disease

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

Sponsors & Collaborators

  • On Target Laboratories, LLC

    collaborator INDUSTRY

  • Indiana University

    collaborator OTHER

  • Clinton Bahler

    lead OTHER

Principal Investigators

  • Clint Bahler, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-02-28
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725523 on ClinicalTrials.gov