Zopocianine for Cancer Detection

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Clinton Bahler

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with biopsy-confirmed prostate cancer who are scheduled for a prostatectomy and lymph node dissection. Specific eligibility details aren't provided, but typically participants must be in good health aside from their cancer and meet certain criteria set by the study.

Inclusion Criteria

Provision of signed and dated informed consent and HIPAA form

I am a man aged 18 or older.

Agree to use a medically acceptable method of birth control or sexual abstinence for the duration of the study

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Exclusion Criteria

History of allergy to specific components of ZOPOCIANINE

Patients with QTc interval ≥ 470 msec per ECG at screening

I do not have any serious health issues that could make the trial unsafe for me.

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Treatment Details

Interventions

OTL78 Injection (Virus Therapy)

Trial OverviewThe trial tests three different doses of Zopocianine (OTL78) given at varying times around surgery day to see if it helps better detect cancerous tissue when used with NIR fluorescent imaging during prostate removal surgeries.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: 0.06mg/kg ZOPOCIANINE given day prior to surgeryExperimental Treatment1 Intervention

A single dose of 0.06mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Group II: 0.03mg/kg ZOPOCIANINE given day prior to surgeryExperimental Treatment1 Intervention

A single dose of 0.03mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Group III: 0.03mg/kg ZOPOCIANINE given day of surgeryExperimental Treatment1 Intervention

A single dose of 0.03mg/kg ZOPOCIANINE (given 1 - 12 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.