Using a special dye to detect lung cancer during surgery
A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures
This study is testing a special dye to see if it can help doctors find lung cancer more easily during surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | panitumumab |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT03582124 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial investigates the optimal dose and timing of panitumumab-IRDye800, a combination of an antibody drug and an investigational dye, to enhance the visibility of lung cancer during surgical procedures. The study aims to compare the effectiveness of this dye in identifying tumor cells versus normal tissue using near-infrared fluorescence imaging. Participants will receive the dye intravenously before undergoing surgery, and the study will assess both the safety of the dye and its ability to detect primary tumors and positive lymph nodes. Follow-up will occur for up to 30 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with lung nodules or masses suspected of malignancy who are scheduled for surgical resection.
Not a fit: Patients with recent serious cardiovascular events or those who have had adverse reactions to monoclonal antibody therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the detection of lung cancer during surgery, potentially leading to better surgical outcomes.
How similar studies have performed: Other studies using similar imaging techniques have shown promise, but this specific approach with panitumumab-IRDye800 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven * Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2 * Hemoglobin ≥ 9 gm/dL * White blood cell count \> 3000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: * Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment * History of infusion reactions to monoclonal antibody therapies * Pregnant or breastfeeding * Magnesium or potassium lower than the normal institutional values * Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis * Prisoners, institutionalized individuals, and patients unable to consent for themselves
Where this trial is running
Palo Alto, California
- Stanford University, School of Medicine — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Lui — Stanford University
- Study coordinator: Natalie Lui
- Email: natalielui@stanford.edu
- Phone: 650-721-2086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.