An interventional study of Ultrasound imaging and Standard Treatment in Tongue Cancer, Oral Cancer and Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, sponsored by Tobias Todsen. Recruiting at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Tobias Todsen · Not applicable, Interventional, and Treatment
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Among 73 studies in Tongue Neoplasms with a site in United States — 8 open to participants now, 11 under way, 2 of them phase 3. Tongue Neoplasms · United States.
Among the 73 studies in Tongue Neoplasms with a site in United States, this one is the 10th largest by planned enrollment of the 61 interventional ones that give a count, is one of 4 that started in 2025, is one of 13 with no phase, reaches primary completion later than 5 of the 10 other live ones, and was the 72nd registered.
121 studies on the registry are indexed under Tongue Neoplasms; 12 are open to participants now.
Browse Tongue Neoplasms studies →8 of the 73 studies in Tongue Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Tongue Neoplasms studies recruiting now, 9 (82%) set no upper age limit and 1 (9%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
73 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 32 · Phase 3 6 · Phase 4 1
First in 1999; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 42 across 93 interventional studies indexed under Tongue Neoplasms.
Median enrollment 43 across the 61 interventional studies, 130 across the 9 observational. Of the 56 that completed or were terminated, 23 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 73 have an industry lead sponsor. The 10 most frequent:
Tobias Todsen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Tobias Todsen has 1 study filed under Tongue Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Tongue Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04870762M.D. Anderson Cancer CenterCustomized 3D Printed Oral Stents During Head and Neck Radiotherapy | 2026-12-31 |
| NCT01473784Ohio State University Comprehensive Cancer CenterTransoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck | 2026-12-31 |
| NCT06915454Vanderbilt-Ingram Cancer CenterHigh-Resolution PET-CT Imaging for Surgical Margin Visualization | 2027-05 |
| NCT07203911Tobias TodsenSurgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial | 2027-09-15 |
Add all 4 to your calendar (.ics) → With an account.
Among the 73 studies in Tongue Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Outcomes:
All participant will be followed-up at 3 months and 12 months with:
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
Exclusion criteria
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.
Other: Standard Treatment
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.
Diagnostic Test: Ultrasound imaging
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 surgical treatment of oral cancer
Surgeon prediction of final margin
Surgeons prediction of deep margin in mm
Time frame: 2 weeks.
Clear Margin
Clear margin rate as a dichotomous outcome (clear vs non-clear)
Time frame: 2 weeks.
Dysphagia questionnaire
MD Anderson Dysphagia Inventory to assess dysphagia at 3 and 12 months.
Time frame: 12 months
Cancer recurrence
This outcome will explore whether the use of ultrasound leads to more complete removal of cancerous tissue.
Time frame: 24 months
Survial
This outcome will explore whether an expected increased frequency of "free surgical margins" in the intervention group also reflects on survival.
Time frame: 24 months
Quality of life questionnaire
EORTC HN43 quality of life questionnaire in order to assess quality of life after head and neck cancer.
Time frame: 12 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact daniel.julius.lauritzen@regionh.dk
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 24 months after the start.
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