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Back|NCT07203911Recruiting
Official Title

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

Sponsor
Tobias Todsen
Enrollment
200
Timeline
Sep 2025 → Aug 2031
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: * 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.

Eligibility Criteria

Inclusion Criteria

  • 1Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.

Exclusion Criteria

  • 1Age \< 18 years.
  • 2Oral cancer with suspected bone involvement.
  • 3Unable to understand verbal or written information.
  • 4Prior radiotherapy treatment of oral cavity cancer.
  • 5Tumor not visible on ultrasound.

Locations

7 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

Stanford Otolaryngology - Head & Neck Surgery Department

Stanford, California 94305

Recruiting

Lisa A Orloff, MD, FACS, FACE

Department of Otorhinolaryngology Head and Neck Surgery

Aarhus, 8200

Recruiting

Thomas Kjærgaard, MD, PhD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →