[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648693":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":59,"collaborators":63,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":19,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":19,"enrollmentInfo":77,"targetDuration":19,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":92,"whyStopped":19,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Indiana University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"0.06mg\u002Fkg ZOPOCIANINE given 1-7 days prior to surgery","EXPERIMENTAL","A single dose of 0.06mg\u002Fkg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.",[13],"Drug: 0.06mg\u002Fkg ZOPOCIANINE given 1-7 days prior to surgery",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","A single dose of 0.06mg\u002Fkg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Clint Bahler, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Brandon Garver","CONTACT","317-278-4766","brwgarve@iu.edu",[31,47],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Indiana University Health North Hospital","Carmel","Indiana","46032","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-86.11804,39.97837,{"lat":42,"lon":41},[45,46],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":48,"status":19,"city":49,"state":34,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Indiana University School of Medicine","Indianapolis","46202",{"type":39,"coordinates":52},[53,54],-86.15804,39.76838,{"lat":54,"lon":53},[57,58],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Clinton Bahler","Associate Professor",[64,67],{"name":65,"class":66},"On Target Laboratories, LLC","INDUSTRY",{"name":5,"class":6},"100648693","phase-2-safety-and-efficacy-of-otl78-zopocianine-100648693",false,"NCT07725523","Safety and Efficacy of OTL78 (Zopocianine)","Safety and Efficacy of OTL78 (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent and HIPAA form\n2. Male participants 18 years of age and older\n3. Known primary prostate cancer and any one of the following:\n\n   1. Grade group 3-5;\n   2. Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);\n   3. Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography\n4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection\n5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments\n6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n7. Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.\n\nExclusion Criteria:\n\n1. The surgeon plans to perform an extraperitoneal approach\n2. History of anaphylactic reactions to products containing indocyanine green\n3. History of allergy to any of the components of ZOPOCIANINE:\n\n   1. 2-\\[3-(1,3-dicarboxypropyl)ureido\\] pentanedioic acid (DUPA)\n   2. Polyethylene glycol-dipeptide linker\n   3. Chlorodye\n4. Impaired renal or hepatic function:\n\n   1. Renal: creatinine clearance (eGFR) \\\u003C 50 mL\u002Fmin\n   2. Hepatic: total bilirubin \\> 2 × upper limit of normal or ALT\u002FAST \\> 3 × upper limit of normal.\n5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.\n6. Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.","MALE","18 Years",{"count":78,"type":79},36,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE2","PHASE3","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.",[86,87],"Prostate Cancer Surgery","Prostate Cancer Metastatic Disease",[89,90,91],"Prostate Specific Membrane Antigen","Fluorescent Imaging","Near infrared imaging","NOT_YET_RECRUITING","2026-07-29",{"date":95,"type":96},"2026-07-30","ACTUAL",{"date":98,"type":79},"2026-09",{"date":100,"type":79},"2027-04",{"name":61,"class":6},2]