Head & Neck CancerNCT07910799
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)
A study testing tissue marker BioXmark in people with Head & Neck Cancer, run by University Hospital, Essen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- tissue marker BioXmark
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- any type and stage of head and neck cancer
- planned radiation therapy (independent of definitive radiation therapy or adjuvant radiation therapy)
Who cannot join
- do not wish to participate in the study
- younger than 18 years
- known allergic reaction to contrast agents or soft tissue markers
- unable to attend the UME Center for routine clinical care
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maja Guberina, PD Dr. med. contact
About this study
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.
Read the detailed description
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.
- Conditions
- Head & Neck Cancer
- Being tested
- tissue marker BioXmark
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue marker BioXmarkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with head and neck cancer receiving the tissue marker BioXmark®. | Experimental | Not described Receives: Other: tissue marker BioXmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2034 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerstin Stähr, University Hospital, Essen
- Investigators
- Kerstin Staehr, PD Dr. med., Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910799
- Sponsor's protocol ID
- BioXMark
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07910799
- Acronym / sponsor ID
- BioXMark
- Conditions
- Head & Neck Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 295 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck cancer receiving the tissue marker BioXmark®. | Experimental | Other: tissue marker BioXmark |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older
- any type and stage of head and neck cancer
- planned radiation therapy (independent of definitive radiation therapy or adjuvant radiation therapy)
Key exclusion criteria (4 listed)
- do not wish to participate in the study
- younger than 18 years
- known allergic reaction to contrast agents or soft tissue markers
- unable to attend the UME Center for routine clinical care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue marker BioXmarkAfter 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. | Other | Patients with head and neck cancer receiving the tissue marker BioXmark®. |
Primary outcome
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
Time frame: 0-10 years
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maja Guberina, PD Dr. med. contact
Kerstin Staehr, PD Dr. med. principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Essen
Questions about this trial
What is this clinical trial studying?
A study testing tissue marker BioXmark in people with Head & Neck Cancer, run by University Hospital, Essen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerstin Staehr, PD Dr. med. (+49 201 / 723-4309, kerstin.staehr@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 0-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.