200
Participants
Start Date
September 15, 2025
Primary Completion Date
September 15, 2027
Study Completion Date
August 31, 2031
Ultrasound imaging
Ultrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In the ex-vivo phase the resected tumor will undergo ultrasound by using a motorized mechanical arm designed to hold an ultrasound transducer. This ensures standardized and reproducible scans. The purpose of the ex-vivo scan is to measure the surgical margins at the operating theatre and allow for an immediate re-resection of necessary. Surgeons in the intervention group will also have the possibility of taking biopsies for frozen section analyses.
Standard Treatment
Standard surgical treatment of oral cancer
NOT_YET_RECRUITING
Groote Schuur, Cape Town
RECRUITING
Department of Otorhinolaryngology Head and Neck Surgery, Aarhus
NOT_YET_RECRUITING
Karolinska Institute, Stockholm
NOT_YET_RECRUITING
Istituto Nazionale Tumori of Milan, Milan
NOT_YET_RECRUITING
Emory University Hospital, Atlanta
NOT_YET_RECRUITING
Stanford Otolaryngology - Head & Neck Surgery Department, Stanford
RECRUITING
Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen
Karolinska Institutet
OTHER
Emory University
OTHER
Stanford University
OTHER
National Cancer Institute, Milan
OTHER
University of Cape Town
OTHER
Aarhus University Hospital
OTHER
Tobias Todsen
OTHER