Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 19 and up

Using a special dye to detect lung cancer during surgery

Official title: 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

Run by Stanford University · NCT03582124 · Data updated 2026-11-12

This study is testing a special dye to see if it can help doctors find lung cancer more easily during surgery.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment30 (estimated)
SponsorStanford University
Academic / other
Drugs / interventionspanitumumab
Locations1 site (Palo Alto, California)
StatusRecruiting
StartedJuly 19, 2018
Main results expectedApril 2027
Study endsApril 2027
Registry record updatedOctober 5, 2026
Trial IDNCT03582124 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with lung nodules or masses suspected of malignancy who are scheduled for surgical resection.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies using similar imaging techniques have shown promise, but this specific approach with panitumumab-IRDye800 is novel.

Who can join: the full rules

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 it's running

  • Stanford University, School of Medicine
    Palo Alto, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.