Tongue CancerSURGIONCT07203911
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
A study testing Ultrasound imaging and Standard Treatment in people with Tongue Cancer and Oral Cancer, run by Tobias Todsen at 7 sites in 5 countries.
Trial summary
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Cancer, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
- What is being tested?
- Ultrasound imaging and Standard Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 15 Sep 2025to Aug 2031
- 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 scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Who cannot join
- Age < 18 years.
- Oral cancer with suspected bone involvement.
- Unable to understand verbal or written information.
- Prior radiotherapy treatment of oral cavity cancer.
- Tumor not visible on ultrasound.
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Merry E Sebelik, 404-778-3381, merry.sebelik@emory.edu
- Not yet recruiting
Stanford Otolaryngology - Head & Neck Surgery Department
Stanford, California, 94305
Lisa A Orloff, MD, FACS, FACE, (650) 736-1680, lorloff@stanford.edu
Michelle Chen, Ass. Prof., michelle.chen@stanford.edu
Denmark2 sites, 2 recruiting
- Recruiting
Department of Otorhinolaryngology Head and Neck Surgery
Aarhus, 8200
Thomas Kjærgaard, MD, PhD, +4578450000, thokjaer@rm.dk
- Recruiting
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet
Copenhagen
Tobias Todsen, MD, PhD, Ass. Prof., +4535453545, tobias.todsen@regionh.dk
Daniel J Lauritzen, MD
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto Nazionale Tumori of Milan
Milan, 20133
Alberto Deganello, +39 02 23901, adeganello@hotmail.com
South Africa1 site, 1 recruiting
- Not yet recruiting
Groote Schuur
Cape Town, 7935
Matthew White, +27 21 404 9111, matthewwhite86@yahoo.com
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institute
Stockholm, 17177
Mathias von Beckerath, +46 8 524 800 00, mathias@beckerath.se
About this study
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer.
Participants will be randomized to either the control or intervention group:
Read more
- Control group will receive standard treatment for oral cancer.
- Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively.
Outcomes:
- Number of free surgical margins between control and intervention group.
- Intraoperative surgeon assessed surgical margins compared to final histology report.
- Dysphagia and quality of life questionnaires.
- Recurrence rates.
- Mortality rates.
All participant will be followed-up at 3 months and 12 months with:
- MDADI dysphagia questionnaire
- EORTC head and neck cancer quality of life questionnaire
- Follow-up on recurrrence and mortality.
Read the detailed description
Background:
Surgery is the primary treatment for early-stage oral cancer, aiming to completely remove the tumor along with a margin of healthy tissue to ensure a clear surgical margin. However, in up to 50% of cases, the tumor is not entirely removed, leading to higher rates of cancer recurrence and mortality. This challenge often arises from difficulty distinguishing tumor tissue from healthy tissue during the operation. Studies have shown that ultrasound can effectively make this distinction. This project investigates using B-mode in-vivo and ex-vivo ultrasound to assist surgeons in the resection of the tumor. The objective is to enhance accuracy during these surgeries by use of ultrasound. Consequently, we hope to minimize the need for adjuvant therapies, potentially enhancing patients' quality of life and reducing cancer recurrence and mortality rates.
Study population:
Inclusion criteria
- Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Exclusion criteria
- Age < 18 years.
- Oral cancer with suspected bone involvement.
- Unable to understand verbal or written information.
- Prior radiotherapy treatment of oral cavity cancer.
- Tumor not visible on ultrasound.
Methods:
We plan to conduct a multicenter randomized controlled trial at seven otorhinolaryngology-Head and Neck Surgery departments in Europe, USA and Africa. The trial is anchored in Rigshospitalet, Copenhagen (Denmark).
Patients who meet the study´s criteria will be assigned either the control - or intervention group.
- Patients in the control group will have surgery for oral cancer conducted following the current standards for each center. The oral cancer tumor will be excised without having an ultrasound machine available to guide the resection. Then, the surgeon will take additional biopsies either from the in-vivo wound edges or from the specimen depending on local guidelines. Then the biopsies will be sent to the pathology department for frozen-section analysis. The surgeon might revise the resection or terminate the operation based on the frozen-section result. If the frozen-section analysis indicates an inadequate margin, the surgeon will, if possible, excise additional tissue from the wound, and the measured margin will be adjusted accordingly.
- In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at their disposal to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. Initially, tumor dimensions are measured using a Fujifilm robotic ultrasound probe or a hockey stick probe, and a 10 mm margin is marked from the tumor's boundaries. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.
After tumor removal, the specimen will undergo an ex-vivo ultrasound scan. In this phase, we will use a motorized mechanical transducer holder to hold the transducer to obtain standardized and reproducible B-mode cross-sectional images of the resected tissue allowing for margin measurement in the operating room. This imaging along with the margin measurements will help surgeons decide whether to perform an immediate re-resection or to conclude the operation. The use of ultrasound will not replace standard procedures, but should instead be viewed as an add-on tool. Therefore, surgeons in the intervention group will have the possibility to take biopsies for frozen section analyses.
- Being tested
- Ultrasound imaging, Standard Treatment
- Medical subject headings
- Tongue Neoplasms, Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingDiagnostic test
Ultrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In the ex-vivo phase the resected tumor will undergo ultrasound by using a motorized mechanical arm designed to hold an ultrasound transducer. This ensures standardized and reproducible scans. The purpose of the ex-vivo scan is to measure the surgical margins at the operating theatre and allow for an immediate re-resection of necessary. Surgeons in the intervention group will also have the possibility of taking biopsies for frozen section analyses.
Standard TreatmentOther
Standard surgical treatment of oral cancer
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The patients in the control group will have surgery for oral cancer conducted following the current standards for each center. Receives: Other: Standard Treatment |
| Intervention | Experimental | In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed. Receives: Diagnostic Test: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon prediction of final margin
Surgeons prediction of deep margin in mm
Measured: 2 weeks.
Secondary outcomes (5)
Clear Margin
Clear margin rate as a dichotomous outcome (clear vs non-clear)
Measured: 2 weeks.
Dysphagia questionnaire
MD Anderson Dysphagia Inventory to assess dysphagia at 3 and 12 months.
Measured: 12 months
Cancer recurrence
This outcome will explore whether the use of ultrasound leads to more complete removal of cancerous tissue.
Measured: 24 months
Survial
This outcome will explore whether an expected increased frequency of "free surgical margins" in the intervention group also reflects on survival.
Measured: 24 months
Quality of life questionnaire
EORTC HN43 quality of life questionnaire in order to assess quality of life after head and neck cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Sep 2025
- Primary completion15 Sep 2027 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will randomized to either 1)standard treatment for oral cancer 2) standard treatment for oral cancer + the use of ultrasound during surgery to guide resection process and evaluate resections margins.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tobias Todsen
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, National Cancer Institute, Milan, Aarhus University Hospital, Odense University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Tobias Todsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203911
- Sponsor's protocol ID
- p-2024-18099
- Acronym
- SURGIO
- Status last verified
- May 2026
- First submitted
- 24 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in surgical treatment of oral cancer. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07203911
- Acronym / sponsor ID
- SURGIO / p-2024-18099
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tobias TodsenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, National Cancer Institute, Milan, Aarhus University Hospital, Odense University Hospital, Aalborg University Hospital
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 2 Oct 2025 (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 goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer.
Participants will be randomized to either the control or intervention group:
- Control group will receive standard treatment for oral cancer.
- Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively.
Outcomes:
- Number of free surgical margins between control and intervention group.
- Intraoperative surgeon assessed surgical margins compared to final histology report.
- Dysphagia and quality of life questionnaires.
- Recurrence rates.
- Mortality rates.
All participant will be followed-up at 3 months and 12 months with:
- MDADI dysphagia questionnaire
- EORTC head and neck cancer quality of life questionnaire
- Follow-up on recurrrence and mortality.
Detailed description
Background:
Surgery is the primary treatment for early-stage oral cancer, aiming to completely remove the tumor along with a margin of healthy tissue to ensure a clear surgical margin. However, in up to 50% of cases, the tumor is not entirely removed, leading to higher rates of cancer recurrence and mortality. This challenge often arises from difficulty distinguishing tumor tissue from healthy tissue during the operation. Studies have shown that ultrasound can effectively make this distinction. This project investigates using B-mode in-vivo and ex-vivo ultrasound to assist surgeons in the resection of the tumor. The objective is to enhance accuracy during these surgeries by use of ultrasound. Consequently, we hope to minimize the need for adjuvant therapies, potentially enhancing patients' quality of life and reducing cancer recurrence and mortality rates.
Study population:
Inclusion criteria
- Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Exclusion criteria
- Age < 18 years.
- Oral cancer with suspected bone involvement.
- Unable to understand verbal or written information.
- Prior radiotherapy treatment of oral cavity cancer.
- Tumor not visible on ultrasound.
Methods:
We plan to conduct a multicenter randomized controlled trial at seven otorhinolaryngology-Head and Neck Surgery departments in Europe, USA and Africa. The trial is anchored in Rigshospitalet, Copenhagen (Denmark).
Patients who meet the study´s criteria will be assigned either the control - or intervention group.
- Patients in the control group will have surgery for oral cancer conducted following the current standards for each center. The oral cancer tumor will be excised without having an ultrasound machine available to guide the resection. Then, the surgeon will take additional biopsies either from the in-vivo wound edges or from the specimen depending on local guidelines. Then the biopsies will be sent to the pathology department for frozen-section analysis. The surgeon might revise the resection or terminate the operation based on the frozen-section result. If the frozen-section analysis indicates an inadequate margin, the surgeon will, if possible, excise additional tissue from the wound, and the measured margin will be adjusted accordingly.
- In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at their disposal to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. Initially, tumor dimensions are measured using a Fujifilm robotic ultrasound probe or a hockey stick probe, and a 10 mm margin is marked from the tumor's boundaries. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.
After tumor removal, the specimen will undergo an ex-vivo ultrasound scan. In this phase, we will use a motorized mechanical transducer holder to hold the transducer to obtain standardized and reproducible B-mode cross-sectional images of the resected tissue allowing for margin measurement in the operating room. This imaging along with the margin measurements will help surgeons decide whether to perform an immediate re-resection or to conclude the operation. The use of ultrasound will not replace standard procedures, but should instead be viewed as an add-on tool. Therefore, surgeons in the intervention group will have the possibility to take biopsies for frozen section analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will randomized to either 1)standard treatment for oral cancer 2) standard treatment for oral cancer + the use of ultrasound during surgery to guide resection process and evaluate resections margins.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard TreatmentThe patients in the control group will have surgery for oral cancer conducted following the current standards for each center. |
| Intervention | Experimental | Diagnostic Test: Ultrasound imagingIn the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Key exclusion criteria (5 listed)
- Age < 18 years.
- Oral cancer with suspected bone involvement.
- Unable to understand verbal or written information.
- Prior radiotherapy treatment of oral cavity cancer.
- Tumor not visible on ultrasound.
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 |
|---|---|---|
| Ultrasound imagingUltrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In the ex-vivo phase the resected tumor will undergo ultrasound by using a motorized mechanical arm designed to hold an ultrasound transducer. This ensures standardized and reproducible scans. The purpose of the ex-vivo scan is to measure the surgical margins at the operating theatre and allow for an immediate re-resection of necessary. Surgeons in the intervention group will also have the possibility of taking biopsies for frozen section analyses. | Diagnostic test | Intervention |
| Standard TreatmentStandard surgical treatment of oral cancer | Other | Control |
Primary outcome
Surgeon prediction of final margin
Time frame: 2 weeks.
Surgeons prediction of deep margin in mm
5 secondary outcomes
Clear Margin
Time frame: 2 weeks.
Dysphagia questionnaire
Time frame: 12 months
Cancer recurrence
Time frame: 24 months
Survial
Time frame: 24 months
Quality of life questionnaire
Time frame: 12 months
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 13 May 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in surgical treatment of oral cancer. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound imaging and Standard Treatment in people with Tongue Cancer and Oral Cancer, run by Tobias Todsen at 7 sites in 5 countries.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Denmark, Italy, South Africa, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Daniel J Lauritzen, MD (+4541817574, daniel.julius.lauritzen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon prediction of final margin (time frame: 2 weeks.). 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 13 May 2026.