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

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ClinicalTrials.gov Identifier: NCT04950166
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : September 21, 2022
Information provided by (Responsible Party):
OncoNano Medicine, Inc.

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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Drug: pegsitacianine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fluorescence imaging with pegsitacianine
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
Drug: pegsitacianine
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
Other Name: ONM-100

Primary Outcome Measures :
  1. Clinically Significant Events (CSE) [ Time Frame: 1 day ]
    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)

Secondary Outcome Measures :
  1. Pegsitacianine safety [ Time Frame: 30 days ]
    Treatment emergent adverse events

  2. Pegsitacianine fluorescence and imaging performance [ Time Frame: 7 days ]
    Sensitivity, specificity, negative and positive predictive values at the level of the individual patient specimens

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950166

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Contact: Trials@OncoNanoMed.com (682) 285-1411 trials@onconanomed.com

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United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stacie Moore, BSN, RN    336-716-6694    snmoore@wakehealth.edu   
Principal Investigator: Edward Levine, MD         
United States, Ohio
The Ohio State University Wexner Medical Center / James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43201
Contact: Lindsay Ingman    614-293-4583    Lindsay.ingman@osumc.edu   
Principal Investigator: Alex Kim, MD         
United States, Pennsylvania
Perelman School of Medicine, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Alexa Mazur    610-724-1431    maza@pennmedicine.upenn.edu   
Principal Investigator: Giorgos Karakousis, MD         
AHN Cancer Institute, West Penn Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Melissa Tian    412-359-3748    Melissa.tian@ahn.org   
Principal Investigator: David Bartlett, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Paul Antaby    713-834-6944    pjantaby@mdanderson.org   
Principal Investigator: Nicole Fleming, MD         
Sponsors and Collaborators
OncoNano Medicine, Inc.
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Responsible Party: OncoNano Medicine, Inc.
ClinicalTrials.gov Identifier: NCT04950166    
Other Study ID Numbers: ON-1003
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases