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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedpegsitacianine and Tumor resection surgery

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 8, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?OncoNano Medicine, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 2
Sponsor: OncoNano Medicine, Inc.
Interventions being studied: Drug: pegsitacianine; Procedure: Tumor resection surgery

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
The University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 8, 2024. Always confirm current availability with the study team.

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