Fluorescent dye to mark nerves may improve head, neck cancer surgery
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A phase 3 clinical trial will evaluate a nerve fluorescing product designed to illuminate nerves during head and neck tumor removal, allowing surgeons to locate them more easily.
Alume Biosciences developed a dye that consists of a fluorescing molecule and a peptide that binds to nerves, making them more clearly visible during surgery.
“One of the complicated aspects of surgery is identifying and preserving nerves. If there’s a possibility of a better way to see these nerves during surgery, this seems like a win for the patient,” researcher Jason Newman, MD, head and neck cancer division director at Medical University of South Carolina Hollings Cancer Center, told Healio. “Trials like this have the potential to provide significant benefits to patients.”
Healio spoke with Newman about the challenges in head and neck cancer surgery, the new technique he is evaluating and the potential advantages of this new approach.
Healio: How challenging is it for surgeons to find and preserve the nerve during surgery to remove head and neck tumors?
Newman: It is one of the biggest technical factors in head and neck surgery. If you think of the fact that the brain is up at the top and the rest of the body is below, it all travels through the neck. The number of things going through there is significant. When you’re doing surgery on this part of the body, the density of the real estate is exceptionally high. When we think about the side effects and risks associated with these surgeries, damage to the nerves is at the top of the list. This definitely needs to be considered during these surgeries.
Healio: How does the new fluorescing product work?
Newman: There are peptides that naturally bind to nerves. We have discovered that if you can find something that naturally binds to nerves, and then if you attach a fluorescent molecule to it, the thing that is binding to the nerve also happens to fluoresce. You can take advantage of that by giving the patient that drug, which is only active temporarily. This fluorescent molecule and peptide combination is given through an IV infusion. Within a half-hour to 1 hour, the nerves inside their body will fluoresce under certain circumstances. You have to wear a light that helps excite the fluorescent molecule at a certain wavelength. These goggles, called loupes, have filters on them. They enable us to see the nerves fluoresce. It only works for a few hours, after which the drug flushes out of the kidneys.
Healio: How is this trial being conducted?
Newman: We have completed the first and second phases, which were to identify the correct dose of this drug and its safety profile. We are in the third phase, which is designed to assess efficacy. Multiple centers are involved in this trial. We’re using this drug under very controlled circumstances to figure out where we can show the most benefit for its use. In the future, we want to be able to say, “Here are the best-case use scenarios for this drug. If you’re doing this surgery under these circumstances, adding this nerve identification peptide fluorescent molecule will improve your ability to get excellent outcomes with this surgery.”
Healio: If this product proves to be effective, what are the potential long-term implications?
Newman: This has the potential to make surgeons who are not experts in this area much better. I have been doing this kind of surgery for over 20 years. When I talk to expert surgeons, sometimes they ask, “What is the benefit? We know how to do the surgery.” Part of my response is that the goal is to try to quickly bring everyone up to expert level as quickly as possible. If you were to walk into the office of a surgeon who looked like they graduated from training a month ago, you would realize that their level of competence and the level of competence of someone who had been doing this for 20 years look a bit different. However, if we know that the difficult part of certain surgeries is identifying and preserving the nerves, giving someone the tools to make those nerves literally glow during surgery will make that nonexpert become better faster. So, part of the goal is to make this surgery as safe as possible for as many patients as possible. This is a rather easy way to impact the most patients, the most surgeons and the goal of getting better outcomes.
Healio: Is there anything else you’d like to mention?
Newman: Generally speaking, I’m interested in every opportunity we have to take what we’re doing and make it better, whether it’s a trial like this one or a drug trial that we think might give patients a better outcome. When people ask me if I know whether something is going to work, the short answer is I never know. However, I am always willing to be one of the people to help decide which direction medicine should be moving in, because we clearly have to keep moving forward until we’re perfect. We’re far from perfect. We need to keep on making differences so we can get there.
Reference:
- MUSC Hollings Cancer Center. Head and neck cancer surgeons test fluorescent dye for marking nerves (press release). Available at https://hollingscancercenter.musc.edu/news/archive/2024/04/22/head-and-neck-cancer-surgeons-test-fluorescent-dye-for-marking-nerves. Published April 22, 2024. Accessed June 8, 2024.
For more information:
Jason Newman, MD, can be reached at newmajas@musc.edu.
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