Lung Cancer
Conditions
Keywords
IRDye800CW, Nimotuzumab, Lung cancer, EGFR, Near infrared, Image guided surgery, Optical imaging
Brief summary
The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.
Interventions
DRUGIRDye800CW-nimotuzumab
50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
Sponsors
Western Economic Diversification Canada
University of Saskatchewan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Surgically resectable Stage I and II non-small cell lung cancer * Able to give informed consent * Age ≥ 18 and ≤ 80 years old * Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon * No prior history of malignancy * No neoadjuvant therapy * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2 * Hemoglobin (hgb) ≥ 90 g/L * White blood cell count (WBC) \> 3 x 109/L * Platelet count (plt) ≥ 100 x 109/L * Serum creatinine ≤ 1.5 times upper reference range
Exclusion criteria
* Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug * Pregnant or nursing * Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment * Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery. | up to 14 days | To identify the dose with the highest tumor fluorescence and TBR. |
| Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery. | up to 14 days | To identify the imaging time with the highest tumor fluorescence and TBR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine primary tumor margins. | up to 14 days | Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue. |
| Identify EGFR positive lymph nodes. | up to 14 days | Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue. |
| Safety of IRDye800CW-nimotuzumab | up to 14 days | a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration. |
Countries
Canada
Contacts
Primary ContactRon Geyer, PhD
Outcome results
None listed