Surgeon-performed ultrasound to guide real-time removal of oral cancer
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 7 sites (Stanford, California and 6 other locations) |
| Trial ID | NCT07203911 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stanford, California and 6 other locations
- Stanford Otolaryngology - Head & Neck Surgery Department — Stanford, California, United States (Not_yet_recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)
- Department of Otorhinolaryngology Head and Neck Surgery — Aarhus, Denmark (Recruiting)
- Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Istituto Nazionale Tumori of Milan — Milan, Italy (Not_yet_recruiting)
- Groote Schuur — Cape Town, South Africa (Not_yet_recruiting)
- Karolinska Institute — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Daniel J Lauritzen, MD
- Email: daniel.julius.lauritzen@regionh.dk
- Phone: +4541817574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.