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

OncoNano Medicine

Status and phase: Completed; Phase 2

Conditions: Peritoneal Carcinomatosis

Treatments: Drug: pegsitacianine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04950166

ON-1003

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Fluorescence imaging with pegsitacianine

Experimental group

Description:

1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.

Treatment:

Drug: pegsitacianine