Clinical trial · Interventional
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
A Phase 2, Single-Dose, Open-Label 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
NCT05048082CI-TRIAL-00082400completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegsitacianine | Drug | — | UNRESOLVED |
| Tumor resection surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorescence imaging with pegsitacianine
- description
- Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
- interventionNames
- Drug: pegsitacianine
- Procedure: Tumor resection surgery
Primary outcomes (1)
- measure
- Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE)
- timeFrame
- 1 day
- description
- 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.
Secondary outcomes (4)
- measure
- Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.