Actively Recruiting
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
Led by Tobias Todsen · Updated on 2026-05-13
150
Participants Needed
7
Research Sites
306 weeks
Total Duration
On this page
Sponsors
T
Tobias Todsen
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
You will not qualify if you...
- Age less than 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.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Stanford Otolaryngology - Head & Neck Surgery Department
Stanford, California, United States, 94305
Not Yet Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
3
Department of Otorhinolaryngology Head and Neck Surgery
Aarhus, Denmark, 8200
Actively Recruiting
4
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
5
Istituto Nazionale Tumori of Milan
Milan, Italy, 20133
Not Yet Recruiting
6
Groote Schuur
Cape Town, South Africa, 7935
Not Yet Recruiting
7
Karolinska Institute
Stockholm, Sweden, 17177
Actively Recruiting
Research Team
D
Daniel J Lauritzen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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