Lipiodal Injection for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a special contrast agent called Lipiodal can help doctors distinguish between healthy and cancerous tissue during surgery for mouth or throat cancer. The goal is to protect healthy tissue from radiation side effects after surgery, which can affect eating and talking. The trial targets patients with advanced mouth or throat cancer who require surgery and reconstruction. Participants will receive Lipiodal during their cancer surgery, and doctors will assess its effectiveness in planning radiation treatment. The study aims to determine if using Lipiodal is safe and practical. As an Early Phase 1 trial, this research focuses on understanding how Lipiodal works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.
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.
What prior data suggests that this method is safe for use in head and neck cancer surgery?
Research has shown that Lipiodal has been safely used in medical settings for over 100 years. One study with bladder cancer patients found Lipiodal to be safe and practical. Another study using Lipiodal as an additional treatment reported no major side effects in patients. These findings suggest that Lipiodal is generally well-tolerated. Although this trial is just beginning, the past use of Lipiodal in other conditions provides some confidence about its safety. Participants will be closely monitored for any side effects and can choose to leave the study at any time.12345
Why are researchers excited about this trial?
Unlike the standard treatments for head and neck cancer, which often involve surgery, chemotherapy, and radiation, Lipiodal injection offers a unique approach by enhancing surgical precision. Lipiodal is a contrast agent injected during surgery to clearly define the boundary between cancerous and healthy tissues. This precise delineation can improve surgical outcomes and aid in radiation planning, potentially leading to more effective treatments with fewer side effects. Researchers are excited because this could mean better-targeted therapies and improved recovery for patients.
What evidence suggests that Lipiodal injection might be an effective treatment for head and neck cancer?
Research has shown that Lipiodal, a contrast agent used for over a hundred years, can enhance imaging during cancer treatments. Some studies suggest that Lipiodal helps identify areas needing treatment, such as in head and neck cancers, which may protect healthy tissues during radiation. Although Lipiodal has been safely used in other cancers, like bladder cancer, this trial focuses on its use during surgery for mouth and throat cancers. Participants in this trial will receive a Lipiodal injection during surgical resection. Early results indicate it could make post-surgery imaging more precise, potentially improving treatment by protecting healthy tissue from radiation.23467
Who Is on the Research Team?
Danielle MacNeil, MD
Principal Investigator
Department of Otolaryngology-Head & Neck Surgery, Western University Canada
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
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
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
Long-term Follow-up
Patients are monitored for safety outcomes and complications through study completion, an average of 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Lipiodal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Western University, Canada
Lead Sponsor