Safety and Efficacy of OTL78 (Zopocianine)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorClinton Bahler
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent and HIPAA form
Male participants 18 years of age and older
Grade group 3-5;
Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
Disqualifiers
The surgeon plans to perform an extraperitoneal approach
History of anaphylactic reactions to products containing indocyanine green
2-[3-(1,3-dicarboxypropyl)ureido] pentanedioic acid (DUPA)
Polyethylene glycol-dipeptide linker
Trial design
Treatments tested in this trial
- 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Clinton Bahler
Lead sponsor
Indiana University
Sponsor institution
On Target Laboratories, LLC
Collaborator
Indiana University
Collaborator
Source ClinicalTrials.gov