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

NCT04950166 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ON-1003
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

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.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 day

Secondary Outcomes (4)

• Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen

  7 days

• Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen

  7 days

• Negative Predictive Value of Pegsitacianine

  7 days

• Positive Predictive Value of Pegsitacianine

  7 days

Study Arms (1)

Fluorescence imaging with pegsitacianine

EXPERIMENTAL

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

Drug: pegsitacianine

Interventions

pegsitacianine DRUG

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

Also known as: ONM-100

Fluorescence imaging with pegsitacianine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Imaging and biopsy confirmed metastatic disease of peritoneal origin

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoNano Medicine, Inc.: lead

Study Sites (5)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University Wexner Medical Center / James Cancer Hospital

Columbus, Ohio, 43201, United States

Location

Perelman School of Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

AHN Cancer Institute, West Penn Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Limitations and Caveats

Trial patients served as their own control since near infrared imaging was withheld until primary completion of surgery, which was defined by the surgeon.

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: OncoNano Medicine, Inc

trials@onconanomed.com

(682) 285-1411

Study Officials

• Patrick Wagner, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: November 30, 2021
• Primary Completion: December 29, 2022
• Study Completion: January 20, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Locations

US (5)