← Back to Search

IRDye800CW-nimotuzumab Imaging for Lung Cancer Surgery

Phase 1 & 2
Recruiting
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 and ≤ 80 years old
Surgically resectable Stage I and II non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days
Awards & highlights

Study Summary

This trial is testing a new way to image tumors during surgery, which may help surgeons better identify and remove cancer cells.

Who is the study for?
This trial is for adults aged 18-80 with Stage I or II non-small cell lung cancer that can be surgically removed. Participants must have good blood counts, no history of other cancers, not received certain anti-cancer drugs recently, and should not be pregnant or nursing. They need to be healthy enough for surgery and without serious heart conditions or lung diseases.Check my eligibility
What is being tested?
The study tests IRDye800CW-nimotuzumab as a probe during lung cancer surgery. It's designed to bind to cancer cells making them visible under near-infrared light which may help surgeons remove the tumor more effectively. The trial aims to find the safest dose and best timing for imaging.See study design
What are the potential side effects?
Potential side effects might include allergic reactions due to sensitivity towards antibodies or NSO derived products used in the investigational drug. Specific side effects are not listed but will likely relate to how the body reacts to this new imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
My lung cancer is in an early stage and can be removed with surgery.
Select...
I have not received any initial treatment before the main treatment.
Select...
I can take care of myself but may not be able to do active work.
Select...
I have never had cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Determine primary tumor margins.
Identify EGFR positive lymph nodes.
Safety of IRDye800CW-nimotuzumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Optimal dose late timeExperimental Treatment1 Intervention
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
Group II: Optimal dose early timeExperimental Treatment1 Intervention
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
Group III: Low dose intermediate timeExperimental Treatment1 Intervention
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
Group IV: High dose intermediate timeExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Western Economic Diversification CanadaOTHER_GOV
1 Previous Clinical Trials
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,374 Total Patients Enrolled

Media Library

IRDye800CW-nimotuzumab Clinical Trial Eligibility Overview. Trial Name: NCT04459065 — Phase 1 & 2
Lung Cancer Research Study Groups: High dose intermediate time, Optimal dose late time, Optimal dose early time, Low dose intermediate time
Lung Cancer Clinical Trial 2023: IRDye800CW-nimotuzumab Highlights & Side Effects. Trial Name: NCT04459065 — Phase 1 & 2
IRDye800CW-nimotuzumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04459065 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the typical usage for IRDye800CW-nimotuzumab?

"IRDye800CW-nimotuzumab is often used as treatment for relapsing. It can also be administered to treat other conditions including advanced head and neck cancer, glioblastoma multiforme (gbm), carcinoma."

Answered by AI

Are there any current vacancies for people looking to enroll in this clinical trial?

"The clinical trial is still recruiting patients, as reflected on the most recent update to the listing on clinicaltrials.gov. This information was first posted on September 1st 2020 and edited May 24th 2022. Currently, 36 participants are needed at a single location."

Answered by AI

IRDye800CW-nimotuzumab has been used in other studies--which ones?

"There are currently 22 clinical trials underway that are studying IRDye800CW-nimotuzumab. Of these, 6 are in Phase 3. The majority of the research is taking place in Changsha, Hunan; however, there 66 total locations running trials for this medication."

Answered by AI

Could I possibly qualify to be a test subject in this research?

"To be eligible for this trial, patients must meet the following requirements: they must have lung cancer, be between 18 and 80 years old, not have undergone neoadjuvant therapy, have a Karnofsky performance status of at least 70% or an ECOG/Zubrod level of 0-2, have adequate cardiopulmonary reserve to undergo surgery as determined by their surgeon."

Answered by AI

Does this research project have an age restriction?

"The age range that is able to enroll in this clinical trial is 18-80 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Steven Bharadwaj 2020. "Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04459065.
~14 spots leftby Sep 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top