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A Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies in Patients Undergoing Routine Surgery

Sponsor
OncoNano Medicine, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05048082
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
6
Anticipated Duration (Months)
20
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
An 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 (SOC) surgery.An 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 (SOC) surgery.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Phase 2, Single-Dose, Open-Label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies, in Patients Undergoing Routine Surgery
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fluorescence imaging with pegsitacianine

Pegsitacianine 1 mg/ml infused 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 Names:
  • ONM-100

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Patients experiencing at least one Clinically Significant Event (CSE) [1 day]

      Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies.

    Secondary Outcome Measures

    1. Frequency and Severity of adverse events related to Pegsitacianine [30 days]

      Treatment emergent adverse events

    2. Pegsitacianine fluorescence and imaging performance [7 days]

      Sensitivity, specificity, negative and positive predictive values of the imaging agent at the level of the individual patient specimens will be calculated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging
    Exclusion Criteria:

    • Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG)

    • Tumor locations the surgeon deems unfeasible to image intraoperatively

    • Excessive and/or generalized disease deemed inoperable by the surgeon

    • Life expectancy less than 12 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    2 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • OncoNano Medicine, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OncoNano Medicine, Inc.
    ClinicalTrials.gov Identifier:
    NCT05048082
    Other Study ID Numbers:
    • ON-1005
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 8, 2022