Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT05048082

Recruitment Status:

Active, not recruiting

Sponsor:

OncoNano Medicine, Inc.

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There are 2 Locations for this study

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Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT05048082

Recruitment Status:

Active, not recruiting

Sponsor:


OncoNano Medicine, Inc.

How clear is this clinincal trial information?

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