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Intraoperative Visualization of Large Head and Neck Tumors to Optimize Radiation Therapy Planning Using Liquid Soft-tissue Markers Such as BioXmark® (During Definitive Treatment or in the Postoperative Setting)
Sponsor: University Hospital, Essen
Summary
The aim of this study is to find out how well BioXmark® can help the investogators to see the tumor area in patients with head and neck cancer. The Investigators want to use this information to better define the area that needs radiation treatment. This may helpt he Investigators treat the tumor more precisely and protect healthy tissue around it. This could reduce side effects from radiation. The Investigators also want to find out whether different types of head and neck tumors can be seen equally well with BioXmark®. During and after treatment, the Investigators will also look at possible side effects and how well important functions are maintained.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
295
Start Date
2026-09
Completion Date
2034-10
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
tissue marker BioXmark
After providing written informed consent, patients will receive an injection of the liquid tissue marker BioXmark® into the tissue surrounding the tumor. The marker will be injected during panendoscopy or after surgical removal of the tumor, depending on the planned treatment. The injection can be performed either endoscopically or through the skin (percutaneously). After the injection, the patient will undergo the imaging examination required for routine diagnosis or treatment planning. The same imaging will be used for routine patient care and to evaluate the tumor margins using BioXmark®. After the imaging examination, patients will continue to receive their planned standard medical care.