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

Recruiting now · Not applicable

Conditions studied: Tongue Cancer, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

In brief

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.

Key facts

Study ID

NCT07203911

Run by

Tobias Todsen

People needed

150

Starts

2025-09-15

Expected to finish

2031-08-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.

You may not qualify if…

• 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.

Where it is running

• Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet — Copenhagen, Denmark (enrolling)
• Department of Otorhinolaryngology Head and Neck Surgery — Aarhus, Denmark (enrolling)
• Karolinska Institute — Stockholm, Sweden (enrolling)
• Stanford Otolaryngology - Head & Neck Surgery Department — Stanford, California, United States
• Istituto Nazionale Tumori of Milan — Milan, Italy
• Emory University Hospital — Atlanta, Georgia, United States
• Groote Schuur — Cape Town, South Africa

Full record on ClinicalTrials.gov

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