Clinical trial · Interventional
Lipiodal Injection Technique for Free Flap Sparing Adjuvant RT Planning in HNC
Lipiodal Injection Technique for Free Flap Sparing Adjuvant Radiation Planning in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipiodal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lipiodal injection
- description
- 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.
- interventionNames
- Drug: Lipiodal
Primary outcomes (2)
- measure
- Success of intra-operative injection
- timeFrame
- Intra-operative
- description
- Successful or unsuccessful injection of Lipiodal
- measure
- Success of visualisation on immediate post-operative and adjuvant radiation planning CT scans
- timeFrame
- Day 5 post-op CT and 6-8 week post-operative radiation planning CT scan
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available