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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
United States
California
Stanford Otolaryngology - Head & Neck Surgery Department
NOT_YET_RECRUITING
Stanford
Georgia
Emory University Hospital
NOT_YET_RECRUITING
Atlanta
Other Locations
Denmark
Department of Otorhinolaryngology Head and Neck Surgery
RECRUITING
Aarhus
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet
RECRUITING
Copenhagen
Italy
Istituto Nazionale Tumori of Milan
NOT_YET_RECRUITING
Milan
South Africa
Groote Schuur
NOT_YET_RECRUITING
Cape Town
Sweden
Karolinska Institute
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Daniel J Lauritzen, MD
daniel.julius.lauritzen@regionh.dk
+4541817574
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2031-08
Participants
Target number of participants: 200
Treatments
Active_comparator: Control
The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.
Experimental: Intervention
In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Karolinska Institutet, Stanford University, National Cancer Institute, Milan, Aarhus University Hospital, University of Cape Town
Leads: Tobias Todsen

This content was sourced from clinicaltrials.gov