Lipiodal Injection for Head and Neck Cancer

Overseen By Agnieszka Dzioba, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Western University, Canada

Disqualifiers: Previous head/neck cancer, Hypersensitivity, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and the use of a contrast agent, it's best to discuss your medications with the trial team to ensure safety.

How does Lipiodal Injection differ from other treatments for head and neck cancer?

Lipiodal Injection is unique because it involves the use of pegylated liposomes for targeted delivery directly into the tumor, which helps retain the drug in the tumor area and nearby lymph nodes longer than traditional methods. This approach aims to enhance the effectiveness of the treatment by concentrating the drug where it's needed most, potentially reducing systemic side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Danielle MacNeil, MD

Principal Investigator

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

Eligibility Criteria

This trial is for patients with advanced mouth or throat cancers who are undergoing surgery and reconstruction with a free flap. They must consent to the use of Lipiodal, a contrast agent, during surgery to potentially spare healthy tissue from post-operative radiation.

Inclusion Criteria

I am 18 or older and a patient at the LHSC head and neck clinic.

My cancer is advanced but hasn't spread beyond the oral cavity and needs major surgery.

Exclusion Criteria

History of hypersensitivity or adverse reaction to Lipiodal or any iodinated radiocontrast

I had surgery or radiation for advanced head and neck cancer.

Clinically apparent cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Injection

Patients undergo surgical resection of head and neck tumors with Lipiodal injection for delineation of the interface between the removed cancer and healthy tissue

Intra-operative

1 visit (in-person)

Post-operative Monitoring

Patients are monitored as inpatients for 7-14 days with twice daily visual reviews of the flap and early post-operative CT scan on day 5

1-2 weeks

Daily inpatient monitoring

Follow-up

Patients are followed with reviews at 1, 4, and 8 weeks post-operatively and receive a post-operative planning CT scan at 6-8 weeks

8 weeks

3 visits (in-person)

Long-term Follow-up

Patients are monitored for safety outcomes and complications through study completion, an average of 6 months

6 months

Treatment Details

Interventions

• Lipiodal

Trial Overview The study tests injecting Lipiodal at surgery time in 10 patients to improve CT imaging of the surgical area. The goal is to see if this can help avoid radiating healthy reconstructed tissue while still targeting cancerous areas.

Participant Groups

Group I: Lipiodal injection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pegylated liposomes have potential as vehicles for intratumoral and subcutaneous drug delivery. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

[Results of combined therapy of irradiation and intra-arterial one-shot injection of cisplatin for head and neck cancers]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Palliative intra-arterial (i.a.) chemotherapy with carboplatin (CBDCA) and 5-FU in unresectable advanced (stage III and IV) head and neck cancer using implantable port-systems. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Induction chemotherapy by superselective intra-arterial high-dose carboplatin infusion for head and neck cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Curative and organ-preserving treatment with intra-arterial carboplatin induction followed by surgery and/or radiotherapy for advanced head and neck cancer: single-center five-year results. [2018]