Study Summary
This trial is testing a new way to image tumors during surgery, which may help surgeons better identify and remove cancer cells.
Eligible Conditions
- Lung Cancer
Treatment Effectiveness
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: up to 14 days
up to 14 days
Determine primary tumor margins.
Identify EGFR positive lymph nodes.
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
Safety of IRDye800CW-nimotuzumab
Trial Safety
Trial Design
4 Treatment Groups
Low dose intermediate time
1 of 4
Optimal dose early time
1 of 4
Optimal dose late time
1 of 4
High dose intermediate time
1 of 4
Experimental Treatment
36 Total Participants · 4 Treatment Groups
Primary Treatment: IRDye800CW-nimotuzumab · No Placebo Group · Phase 1 & 2
Low dose intermediate time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: DrugOptimal dose early time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: DrugOptimal dose late time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: DrugHigh dose intermediate time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 days
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
237 Previous Clinical Trials
90,279 Total Patients Enrolled
Western Economic Diversification CanadaOTHER_GOV
1 Previous Clinical Trials
Eligibility Criteria
Age 18 - 80 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The person has a Karnofsky performance status of at least 70% or an Eastern Cooperative Oncology Group (ECOG)/Zubrod level of 0-2.
The patient has enough reserve in their heart and lungs to undergo surgery to remove a section of their lung
(NSCLC) is the disease that can be cured by surgical resection
People aged between 18 and 80 years old.
You have a white blood cell count (WBC) > 3 x 109/L.
The platelet count is ≥ 100 x 109/L.
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Conditions
Cancer Related
Treatments