An interventional study of tissue marker BioXmark in Head & Neck Cancer, sponsored by University Hospital, Essen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University Hospital, Essen · Not applicable, Interventional, and Diagnostic
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.
Head and neck cancer is a common type of cancer. There are different types of head and neck cancer, and the cancer can occur in different areas of the head and neck. Treatment therefore depends on the type, location, and stage of the cancer.
Treatment may include surgery, radiation therapy, chemotherapy, or a combination of these treatments.
For successful treatment, it is important to know the exact location and extent of the cancer. During radiation therapy, the treatment area should be defined as precisely as possible. This helps to treat the cancer while limiting radiation exposure to healthy tissue nearby. Reducing the amount of healthy tissue exposed to radiation may help to reduce side effects and preserve important functions and quality of life.
However, it is not always possible to clearly distinguish cancer tissue from healthy tissue using medical imaging or physical examination. Therefore, a larger area may need to be treated during radiation therapy to make sure that the entire cancer area is covered. This can result in more radiation exposure to healthy tissue and may increase the risk of side effects.
BioXmark®
BioXmark® is a liquid tissue marker that can help doctors identify soft tissue on CT and MRI scans. It is injected into the tissue near the cancer and forms a small gel-like marker that can be seen on medical images.
BioXmark® has been approved for medical use in Europe and can be used in patients with head and neck cancer. Unlike some metal markers, BioXmark® causes only small disturbances on CT and MRI images.
The marker can remain visible at the injection site for up to approximately two months. It is biodegradable and is gradually broken down and absorbed by the body.
Purpose of the Study
The purpose of this study is to evaluate how well BioXmark® can be used to identify the cancer area in patients with head and neck cancer.
The study will investigate whether BioXmark® can provide a more precise view of the cancer area and whether this information can be used to improve radiation treatment planning.
The study will also investigate whether different types of head and neck cancer can be visualized differently using BioXmark®.
In addition, patients will be monitored during and after radiation therapy for treatment-related side effects and for the preservation of important functions.
The information collected in this study may help to improve the planning and delivery of radiation therapy for patients with head and neck cancer in the future.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 295 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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.
Tumor visualization: Assessment of how clearly the tumor and its margins can be identified on medical imaging using BioXmark®. Radiation dose: Assessment of the radiation dose delivered based on the objective imaging and treatment data. Patient-reported
Objective Data: * Determination of the clinical target volume for radiation planning with and without markers (ml) * Artifact formation (Lickert-scale; 0= none, 1=low, 2=major) Subjective perceptions: * Dysphagia (assessed during treatment visits; established (inter)national questionnaires (H\&N43 (EORTC 0-100 Points), MDADI (20-100 Points)) * Dysphonia (assessed during treatment visits; established (inter)national questionnaires (H\&N43 (EORTC 0-100 Points)) * Quality of life (EQ-5D-5L(0-100 Points) Clinical data (all data are collected as part of routine clinical practice for diagnostic purposes): * Tumor entity: Tumor in the head and neck region with an indication for radiation therapy * Age (years) * Gender (m/f/d) * Staging (TNM categories) * Location * Treatment modalities (Surgery/Chemo/Radiotheorpy/immunotherapy/multiple answere options) * Molecular pathological characteristics of the tumor and its microenvironment (standard of care)
Time frame: 0-10 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2034, 97 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 97 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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