A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Fluorescence imaging with pegsitacianine	pegsitacianine	1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients That Had at Least One Additional Lesion Detected Under Pegsitacianine Guidance Following CRS That Was Confirmed as Positive for Disease by Pathological Evaluation	1 day	Percentage of patients that had at least one additional lesion detected under pegsitacianine guidance following standard of care cytoreductive surgery that would have been left behind had imaging not been performed and was confirmed to be positive for disease by pathological evaluation.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen	7 days	# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens)
Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen	7 days	# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)
Negative Predictive Value of Pegsitacianine	7 days	# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)
Positive Predictive Value of Pegsitacianine	7 days	# of true positive specimens divided by the (# of true positive + # of false positive specimens)

Locations (5): The Ohio State University Wexner Medical Center / James Cancer Hospital
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Columbus, Ohio, United States
Perelman School of Medicine, University of Pennsylvania
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Philadelphia, Pennsylvania, United States
AHN Cancer Institute, West Penn Hospital
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Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
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Houston, Texas, United States
Wake Forest Baptist Health
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Winston-Salem, North Carolina, United States