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NCT06849544 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery, sponsored by Clinton Bahler.

Recruiting
Registry status
Phase 2
Development phase
22
Enrollment target
3
Study locations

NCT06849544 is a Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery that is actively recruiting participants, run by Clinton Bahler. The registered enrollment target is 22 participants, below the 51-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT06849544, a Phase 2 study of Prostate Cancer Metastatic Disease and Prostate Cancer Surgery, is actively recruiting participants, sponsored by Clinton Bahler.

RECRUITING
Registry status
Phase 2
Development phase
22 participants
Enrollment target
3
Study locations

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 Studied

Prostate Cancer Metastatic Disease Prostate Cancer Surgery

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, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 51-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (57% lower). The listed sponsor is Clinton Bahler, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT06849544 reports 3 study locations spanning 1 distinct geographic area - top geographies include Indiana.

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.

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).

Who is sponsoring clinical trial NCT06849544?

This trial is sponsored by Clinton Bahler, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.