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NOT YET RECRUITING
NCT06806189
EARLY_PHASE1

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

Sponsor: Western University, Canada

View on ClinicalTrials.gov

Summary

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.

Official title: Lipiodal Injection Technique for Free Flap Sparing Adjuvant Radiation Planning in Head and Neck Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-04-01

Completion Date

2026-12-31

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

DRUG

Lipiodal

Injection of lipiodal for delineation of interface between the removed mouth/throat cancer and the healthy tissue reconstructing the defect for radiation planning.

Locations (1)

Western University

London, Ontario, Canada