Lipiodal Injection Technique for Free Flap Sparing Adjuvant RT Planning in HNC

What this study is about

Patients with advanced mouth/throat cancers require surgery to remove the cancer followed by reconstruction with transplanted skin/muscle/bone from another location in their body to restore function. This is called a free-flap (skin/muscle/bone used from another part of the body to reconstruct the cancer site). Post-operative radiation therapy is often recommended to reduce the risk of cancer coming back. Unfortunately, radiation can exacerbate issues with swallowing and speech and lead to other complications. To date, there has been no mechanism to allow sparing of the healthy tissue from radiation while ensuring delivery to all at-risk areas. This is a proof-of-principle study that injects a safe contrast agent (material injected to enhance x-ray and ct images) at the time of surgery to improve delineation of the interface between the removed mouth/throat cancer and the healthy tissue reconstructing the defect. In doing so, the investigators hope to demonstrate the potential to spare post-operative radiation to the healthy reconstructive tissue and improve patient function. The investigators propose using Lipiodal, a poppyseed oil-extract that has been in safe clinical use for \> 100-years, in 10 patients. There will be no change to the way in which patients are treated for their mouth/throat cancer or in the way radiation is delivered. The investigators will assess the feasibility and safety of injecting Lipiodal at the time of surgery and visualization on post-operative CT scans. This has been shown to be both safe and feasible in patients with other cancers, such as bladder cancer, however patients will be closely monitored for any side effects. Patients will provide informed consents and be able to withdraw at any time.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)
• Locally advanced T2-4N0-3M0 mucosal or cutaneous squamous cell carcinoma involving the oral cavity requiring composite resection and free flap reconstruction

🚫 You may not be able to join if…

• Previous treated locally advanced head and neck cancer with surgery and/or radiation
• History of hypersensitivity or adverse reaction to Lipiodal or any iodinated radiocontrast
• Severe bronchial asthma
• Severe renal dysfunction
• Hyperthyroidism
• Pregnant
• Breastfeeding
• Clinically apparent cognitive impairment

Where this trial is running

• Western University, London, Ontario, Canada

Who to contact

Agnieszka Dzioba, PhD · 519-685-8500 · Agnieszka.Dzioba@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06806189.