Phase 2
Completed N=20
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
Source: ClinicalTrials.gov NCT05048082 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Nov 2024
Primary outcomePrimary: Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) — 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) |
2 | — |
| SECONDARY Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen |
.32 | — |
| SECONDARY Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen |
.33 | — |
| SECONDARY Negative Predictive Value of Pegsitacianine |
.071 | — |
| SECONDARY Positive Predictive Value of Pegsitacianine |
.75 | — |
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
Data sourced from ClinicalTrials.gov (NCT05048082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.