A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases in Patients Undergoing Cytoreductive Surgery

Study Overview
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Brief Summary
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Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to  5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.

Official Title
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A Phase 2, Single-Dose, Open-Label Study to Evaluate the Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases, in Patients Undergoing Cytoreductive Surgery

Conditions
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Peritoneal Carcinomatosis

Intervention / Treatment
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* Drug: pegsitacianine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging and biopsy confirmed metastatic disease of peritoneal origin Exclusion Criteria: Known hypersensitivity or allergy to any component of pegsitacianine Tumor locations the surgeon deems unfeasible to image intraoperatively Excessive and/or generalized metastatic disease deemed inoperative by the surgeon

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A two group interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence imaging with pegsitacianine<br>1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery. | Drug: pegsitacianine<br>* An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).<br>* Other names: ONM-100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Events (CSE) | Detection of residual disease following standard of care (SOC) resection of peritoneal metastases. Detection of a single additional tumor-containing specimen excised as a result of pegsitacianine fluorescence will be deemed a clinically significant event (CSE) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pegsitacianine safety | Treatment emergent adverse events | 30 days | 
| Pegsitacianine fluorescence and imaging performance | Sensitivity, specificity, negative and positive predictive values at the level of the individual patient specimens | 7 days |