RecruitingPHASE1, PHASE2INTERVENTIONAL

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

This research is investigating a new approach to make lung cancer surgery more precise. The study uses a special substance called IRDye800CW-nimotuzumab, which is designed to light up cancer cells during an operation. This glow could help surgeons see the cancer more clearly, ensuring they remove as much of it as possible. The main goals of this study are to check if this new substance is safe, figure out the best amount to use, and determine the ideal time to give it to patients before surgery. This information will help doctors understand if this method can improve how lung cancer is surgically treated.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Saskatchewan

Enrolment target

Start

01 Sep 2020

Estimated completion

01 Oct 2026

Lung Cancer

What is this study about?

Imagine surgeons having a special light that helps them see hidden cancer areas more clearly during an operation. That's essentially what this study is exploring for lung cancer. The study is investigating a new substance called IRDye800CW-nimotuzumab. This substance is designed to attach specifically to certain types of lung cancer cells, making them glow under a special camera that uses "near-infrared" light. This glow could act like a guide for surgeons, helping them pinpoint cancer cells that might be hard to see with the naked eye.

The main idea is that by making the cancer more visible, surgeons might be able to remove all of it more effectively, potentially leading to better outcomes for patients. This research is in its early stages (Phase 1 and 2), which means the doctors are trying to find out if this substance is safe for people to use, what the best dose is, and when to give it to patients to get the best glowing effect during surgery.

Ultimately, if this new technique proves to be safe and effective, it could become a valuable tool for doctors performing lung cancer surgery. It's about giving surgeons more information during the operation to help them do the best possible job.

Key takeaways

This study is testing a new dye to help surgeons see lung cancer during operations.
The dye makes cancer cells glow under special light.
The aim is to improve the accuracy of lung cancer surgery.
It's a Phase 1/2 study, focused on safety, dosage, and timing.
Participation involves receiving the dye before surgery and follow-up checks.

Who may be eligible?

This study is looking for people aged between 18 and 80 years old who have lung cancer that needs surgery. Specifically, it's for those with early-stage lung cancer (Stage I or II) that can be removed with an operation.

You can’t have had any other cancer in the past and shouldn't have had any chemotherapy or radiation therapy for your lung cancer yet. You also need to be generally fit enough for the operation, with your heart and lungs working well. Some health conditions, like severe heart problems, a history of certain lung diseases, or being pregnant or breastfeeding, might mean you can't join.

Also, if you've had specific antibody treatments for cancer recently, or have known allergies to certain medications, you might not be able to take part. Your blood test results also need to be within a healthy range.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Do you have early-stage lung cancer that needs surgery?
Have you never had any other type of cancer before?
Have you not had chemotherapy or radiation for your lung cancer yet?
Are you generally fit enough for an operation, with good heart and lung health?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a thorough check-up to make sure it's safe for you. If you qualify, you will receive a single dose of the study drug, IRDye800CW-nimotuzumab, a few days before your lung cancer surgery. The drug will be given as an injection.

During your lung cancer surgery, doctors will use special cameras to see if the drug helps highlight the cancer cells. You will have several follow-up appointments after your surgery to check how you are recovering and to monitor for any side effects. This will involve physical examinations, blood tests, and possibly some scans. The total duration of your participation in the study will depend on the follow-up schedule determined by the researchers.

Potential risks and benefits

Potential benefits of taking part in this study are mainly for future patients, as this research aims to improve surgical techniques for lung cancer. For participants, there's a chance the special dye could help surgeons be more thorough during your operation, but this isn't guaranteed. Like all medications, the study drug might cause side effects, which doctors will monitor closely. There might also be risks associated with the extra tests or procedures. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

St. Paul's Hospital
Verified postcode
Saskatoon, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to see if a special dye can help surgeons find lung cancer more easily during operations.

What is IRDye800CW-nimotuzumab?

It's a special substance designed to attach to lung cancer cells and glow under a certain light, helping surgeons see them.

Will this drug cure my cancer?

No, this is not a cancer treatment. It's being studied as a tool to help guide surgery, not to cure the cancer itself.

Who can join this study?

People with early-stage lung cancer who are having surgery, are between 18 and 80, and meet other health requirements.

What does taking part involve?

You'll receive the study drug before surgery, and doctors will use special cameras during your operation. There will also be follow-up appointments.

How to find out more

Ron Geyer, PhD

ron.geyer@usask.ca 306-966-12040 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.