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

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

September 15, 2027

Study Completion Date

August 31, 2031

Conditions
Tongue CancerOral CancerSquamous Cell Carcinoma of the Oral Cavity or Oropharynx
Interventions
DIAGNOSTIC_TEST

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.

OTHER

Standard Treatment

Standard surgical treatment of oral cancer

Trial Locations (7)

7935

NOT_YET_RECRUITING

Groote Schuur, Cape Town

8200

RECRUITING

Department of Otorhinolaryngology Head and Neck Surgery, Aarhus

17177

NOT_YET_RECRUITING

Karolinska Institute, Stockholm

20133

NOT_YET_RECRUITING

Istituto Nazionale Tumori of Milan, Milan

30322

NOT_YET_RECRUITING

Emory University Hospital, Atlanta

94305

NOT_YET_RECRUITING

Stanford Otolaryngology - Head & Neck Surgery Department, Stanford

Unknown

RECRUITING

Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

collaborator

Emory University

OTHER

collaborator

Stanford University

OTHER

collaborator

National Cancer Institute, Milan

OTHER

collaborator

University of Cape Town

OTHER

collaborator

Aarhus University Hospital

OTHER

lead

Tobias Todsen

OTHER

NCT07203911 - Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial | Biotech Hunter | Biotech Hunter