A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
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.
Checked against the public recordLast updated Nov 8, 2024 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.