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Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial

Recruiting

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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.

About the 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:

* 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.

What is being tested

Ultrasound imaging (diagnostic test)
Standard Treatment (other)

Sponsor: Tobias Todsen · Participants: 150 · Started: Sep 15, 2025

Contact the study team

Daniel J Lauritzen, MD · Phone: +4541817574

Official record on ClinicalTrials.gov — NCT07203911

Locations in the U.S.

California	Stanford Otolaryngology - Head & Neck Surgery Department, Stanford (Not yet recruiting)
Georgia	Emory University Hospital, Atlanta (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.