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

NCT06806189 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 126129
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Radiation planning; Head and neck cancer; Tumor delineation

Outcome Measures

Primary Outcomes (2)

• Success of intra-operative injection

  Successful or unsuccessful injection of Lipiodal

  Intra-operative

• Success of visualisation on immediate post-operative and adjuvant radiation planning CT scans

  Success of visualisation of tumour bed-free flap interface

  Day 5 post-op CT and 6-8 week post-operative radiation planning CT scan

Secondary Outcomes (2)

• Complications of injection to the flap tissue

  Intra-operatively, immediately post-operatively, through study completion, an average of 6 months

• Safety outcomes

  Immediately post-operatively, through study completion, an average of 6 months

Study Arms (1)

Lipiodal injection

EXPERIMENTAL

Injection of contrast agent, Lipiodal, during surgical resection of head and neck cancer, for delineation of the interface between the removed mouth/throat cancer and the healthy tissue reconstructing the defect for radiation planning.

Drug: Lipiodal

Interventions

Lipiodal DRUG

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

Lipiodal injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Danielle MacNeil, MD

  Department of Otolaryngology-Head & Neck Surgery, Western University Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Dzioba, PhD

CONTACT

519-685-8500; Agnieszka.Dzioba@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intra-operative injection of lipiodal, a contrast agent (material injected to enhance x-ray and ct images) at the time of head and neck resection surgery to improve delineation of the interface between the removed mouth/throat cancer and the healthy tissue reconstructing the defect.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 3, 2025
• Study Start: April 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)