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RECRUITING Phase 2

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

NCT06849544 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG 0.03mg/kg ZOPOCIANINE given day of surgery
  • DRUG 0.06mg/kg ZOPOCIANINE given day of surgery
  • DRUG 0.03mg/kg ZOPOCIANINE given day prior to surgery
  • DRUG 0.06mg/kg ZOPOCIANINE given days prior to surgery

Study Locations (3)

Indiana

  • Indiana University Health North Hospital — Carmel
  • Indiana University Health Methodist Hospital — Indianapolis
  • Indiana University School of Medicine — Indianapolis

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2025-04-02
Est. Completion 2026-06
Phase Phase 2

Sponsor

Clinton Bahler

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06849544

The ClinicalTrials.gov registry entry for NCT06849544 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clinton Bahler, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Prostate Cancer Metastatic Disease appearing as the primary indexed condition, and to 4 interventions — of which 0.03mg/kg ZOPOCIANINE given day of surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06849544 reports 3 study locations spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06849544 about?

NCT06849544 is a clinical study titled "Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection". 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 prosta...

What is the current status of trial NCT06849544?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2025-04-02. Estimated completion is 2026-06.

What conditions does trial NCT06849544 study?

This clinical trial studies the following conditions: Prostate Cancer Metastatic Disease, Prostate Cancer Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06849544?

The interventions under investigation include: 0.03mg/kg ZOPOCIANINE given day of surgery (DRUG), 0.06mg/kg ZOPOCIANINE given day of surgery (DRUG), 0.03mg/kg ZOPOCIANINE given day prior to surgery (DRUG), 0.06mg/kg ZOPOCIANINE given days prior to surgery (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06849544?

This trial is sponsored by Clinton Bahler, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06849544 being conducted?

This trial has 3 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial