MedTrace Logo

Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection

NCT06849544 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-05-05

No results posted yet for this study

Summary

This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Conditions

  • Prostate Cancer Surgery
  • Prostate Cancer Metastatic Disease

Interventions

DRUG

0.03mg/kg ZOPOCIANINE given day of surgery

A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.06mg/kg ZOPOCIANINE given day of surgery

A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.03mg/kg ZOPOCIANINE given day prior to surgery

A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

DRUG

0.06mg/kg ZOPOCIANINE given 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

  • Indiana University

    collaborator OTHER

  • On Target Laboratories, LLC

    collaborator INDUSTRY

  • Clinton Bahler

    lead OTHER

Principal Investigators

  • Clint Bahler, MD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-07-31
Completion
2026-08-31
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 NCT06849544 on ClinicalTrials.gov