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Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
RECRUITINGPhase 1/2Sponsored by Stanford University
Actively Recruiting
PhasePhase 1/2
SponsorStanford University
Started2018-07-19
Est. completion2026-09
Eligibility
Age19 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03582124
Summary
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
Eligibility
Age: 19 Years+Healthy volunteers accepted
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
Conditions7
CancerLung CancerLung CarcinomaMetastatic Malignant Neoplasm in the LungStage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8
Locations1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
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Actively Recruiting
PhasePhase 1/2
SponsorStanford University
Started2018-07-19
Est. completion2026-09
Eligibility
Age19 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03582124