Surgeon-performed ultrasound to guide real-time removal of oral cancer
Official title: Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
Run by Copenhagen University Hospital, Rigshospitalet · NCT07203911 · Data updated 2026-11-12
This will test whether surgeons using ultrasound during operations can more often remove oral cancers with clear margins in adults with T1–T3 oral squamous cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 7 sites (Stanford, California and 6 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 15, 2027 |
| Study ends | August 2031 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07203911 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with biopsy-proven T1–T3 oral squamous cell carcinoma who are scheduled for surgical resection and whose tumor is visible on ultrasound are the ideal candidates.
✕Probably not a fit
Patients with suspected bone involvement, prior radiotherapy to the oral cavity, tumors not visible on ultrasound, or those unable to consent are unlikely to benefit from the ultrasound-guided approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants are randomized at multiple centers to receive standard surgical treatment for oral cancer with or without surgeon-performed intraoperative ultrasound guidance using B-mode imaging in vivo and ex vivo. The intervention is intended to help surgeons distinguish tumor from healthy tissue during resection and to evaluate margins immediately in the operating room. The trial is multicenter (sites in Europe, the USA, and Africa) and is anchored at Rigshospitalet, Copenhagen. Primary and downstream outcomes include frequency of clear surgical margins, need for adjuvant therapy or reoperation, recurrence, mortality, and patient quality of life.
Why it matters
Potential benefit: If successful, using ultrasound during surgery could increase complete tumor removal, reduce the need for additional treatments or repeat operations, and lower recurrence and mortality while improving quality of life.
How similar studies have gone: Smaller diagnostic and single-center studies have shown ultrasound can distinguish tumor from healthy tissue, but multicenter randomized evidence for surgeon-performed intraoperative ultrasound is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Otorhinolaryngology Head and Neck Surgery
Aarhus, Denmark Recruiting -
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet
Copenhagen, Denmark Recruiting -
Karolinska Institute
Stockholm, Sweden Recruiting -
Stanford Otolaryngology - Head & Neck Surgery Department
Stanford, California, United States Not yet recruiting -
Emory University Hospital
Atlanta, Georgia, United States Not yet recruiting -
Istituto Nazionale Tumori of Milan
Milan, Italy Not yet recruiting
Show 1 more location
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Groote Schuur
Cape Town, South Africa Not yet recruiting
Study contacts
- Study coordinator: Daniel J Lauritzen, MD
- Email: daniel.julius.lauritzen@regionh.dk
- Phone: +4541817574
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.