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| Name | Class |
|---|---|
| Western Economic Diversification Canada | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose intermediate time | Experimental | Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration |
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| High dose intermediate time | Experimental | Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration |
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| Optimal dose early time | Experimental | Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration |
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| Optimal dose late time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRDye800CW-nimotuzumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery. | To identify the dose with the highest tumor fluorescence and TBR. | up to 14 days |
| Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery. | To identify the imaging time with the highest tumor fluorescence and TBR. | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine primary tumor margins. | Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue. | up to 14 days |
| Identify EGFR positive lymph nodes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ron Geyer, PhD | Contact | 306-966-12040 | ron.geyer@usask.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Recruiting | Saskatoon | Saskatchewan | S7M 0Z9 | Canada |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
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Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration |
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Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
| up to 14 days |
| Safety of IRDye800CW-nimotuzumab | 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. | up to 14 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |