Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial (NCT07203911)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (6 items).
Location: Stanford Otolaryngology - Head & Neck Surgery Department — Stanford, California
Age range: 18 Years
🧪 Interventions in This Study
- Ultrasound imaging (DIAGNOSTIC_TEST)
- Standard Treatment (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Stanford Otolaryngology - Head & Neck Surgery Department — Stanford, California
- Emory University Hospital — Atlanta, Georgia
- Department of Otorhinolaryngology Head and Neck Surgery — Aarhus,
- Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet — Copenhagen,
- Istituto Nazionale Tumori of Milan — Milan,
- Groote Schuur — Cape Town,
- Karolinska Institute — Stockholm,
📞 Contact the Study Coordinator
Phone: (454) 181-7574
Email: daniel.julius.lauritzen@regionh.dk
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.