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

Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950166
• Other study ID #: ON-1003
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: July 2023
• Source: OncoNano Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 20, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Drug:
• pegsitacianine
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
OncoNano Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pegsitacianine safety	Treatment emergent adverse events	30 days
Secondary	Pegsitacianine fluorescence and imaging performance	Sensitivity, specificity, negative and positive predictive values at the level of the individual patient specimens	7 days