A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases in Patients Undergoing Cytoreductive Surgery
Primary Purpose
Peritoneal Carcinomatosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegsitacianine
Sponsored by
About this trial
This is an interventional diagnostic trial for Peritoneal Carcinomatosis
Eligibility Criteria
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
Sites / Locations
- Wake Forest Baptist Health
- The Ohio State University Wexner Medical Center / James Cancer Hospital
- Perelman School of Medicine, University of Pennsylvania
- AHN Cancer Institute, West Penn Hospital
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluorescence imaging with pegsitacianine
Arm Description
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Pegsitacianine safety
Treatment emergent adverse events
Pegsitacianine fluorescence and imaging performance
Sensitivity, specificity, negative and positive predictive values at the level of the individual patient specimens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04950166
Brief Title
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases in Patients Undergoing Cytoreductive Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoNano Medicine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluorescence imaging with pegsitacianine
Arm Type
Experimental
Arm Description
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
Intervention Type
Drug
Intervention Name(s)
pegsitacianine
Other Intervention Name(s)
ONM-100
Intervention Description
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
Primary Outcome Measure Information:
Title
Clinically Significant Events (CSE)
Description
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)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pegsitacianine safety
Description
Treatment emergent adverse events
Time Frame
30 days
Title
Pegsitacianine fluorescence and imaging performance
Description
Sensitivity, specificity, negative and positive predictive values at the level of the individual patient specimens
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University Wexner Medical Center / James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Perelman School of Medicine, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
AHN Cancer Institute, West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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