Status:
RECRUITING
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Western Economic Diversification Canada
Conditions:
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 sur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04459065
Start Date
September 1 2020
End Date
October 1 2026
Last Update
January 9 2024
Active Locations (1)
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1
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada, S7M 0Z9