St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9, Canada
Location status: Recruiting
Location contact
Humphrey Fonge, PhD
SUB_INVESTIGATOR
Kris Barreto, PhD
SUB_INVESTIGATOR
Ronald Geyer, PhD
SUB_INVESTIGATOR
Wendy Bernhard, PhD
SUB_INVESTIGATOR
NCT Number: NCT04459065
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Saskatoon, Saskatchewan, S7M 0Z9, Canada
Location status: Recruiting
Humphrey Fonge, PhD
SUB_INVESTIGATOR
Kris Barreto, PhD
SUB_INVESTIGATOR
Ronald Geyer, PhD
SUB_INVESTIGATOR
Wendy Bernhard, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: up to 14 days
To identify the dose with the highest tumor fluorescence and TBR.
Time frame: up to 14 days
To identify the imaging time with the highest tumor fluorescence and TBR.
Time frame: up to 14 days
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Time frame: up to 14 days
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Saskatchewan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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