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Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
Recruiting
I'm InterestedTrial ID: NCT03582124
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
Stanford Investigator(s)
Natalie Shaubie Lui
Assistant Professor of Cardiothoracic Surgery (Thoracic Surgery)
Eligibility
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
Intervention(s):
procedure: Near-Infrared Fluorescence Imaging
drug: Panitumumab-IRDye800
other: Pharmacokinetic Study
procedure: Therapeutic Conventional Surgery
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jake Jungmin Kim
jakejkim@stanford.edu