A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies

NCT05048082 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ON-1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion 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 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

Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.

Drug: pegsitacianine; Procedure: Tumor resection surgery

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

Tumor resection surgery PROCEDURE

Standard of care surgical removal of cancerous lung lesion

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:

• Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoNano Medicine, Inc.: lead

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• A Phase 2 Multicenter Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer with a pH-Activatable Nanoprobe

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

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

trials@onconanomed.com

(682) 285-1411

Study Officials

• Sunil Singhal, MD

  Penn Medicine

  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: 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.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: April 13, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)