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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048082
• Other study ID #: ON-1005
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2022
• Est. completion date: August 31, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• 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 University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

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	Rate of Patients experiencing at least one Clinically Significant Event (CSE)	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.	1 day
Secondary	Frequency and Severity of adverse events related to Pegsitacianine	Treatment emergent adverse events	30 days
Secondary	Pegsitacianine fluorescence and imaging performance	Sensitivity, specificity, negative and positive predictive values of the imaging agent at the level of the individual patient specimens will be calculated	7 days