Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

Trial ID or NCT#

NCT03582124

Status

recruiting iconRECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Natalie Shaubie Lui
Natalie Shaubie Lui
Thoracic surgeon
Assistant Professor of Cardiothoracic Surgery (Thoracic Surgery)

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Contact

Jake Jungmin Kim
jakejkim@stanford.edu

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View on ClinicalTrials.gov