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

NCT07203911 | Recruiting FDA Device

• 1 other identifier: p-2024-18099
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 7

Brief 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.

Conditions

Tongue Cancer; Oral Cancer; Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Outcome Measures

Primary Outcomes (1)

• Free surgical margin

  Free surgical margin defined as resection margin above 5mm on final histopathology report. Reported as dichotomous variable "free surgical margin yes/no"

  2 weeks.

Secondary Outcomes (5)

• Surgeon assessed margins

  2 weeks.

• Dysphagia questionnaire

  12 months

• Cancer recurrence

  24 months

• Survial

  24 months

• Quality of life questionnaire

  12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.

Other: Standard Treatment

Intervention

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound imaging

Interventions

Ultrasound imaging DIAGNOSTIC_TEST

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.

Intervention

Standard Treatment OTHER

Standard surgical treatment of oral cancer

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tobias Todsen: lead
• Emory University: collaborator
• Karolinska Institutet: collaborator
• Stanford University: collaborator
• National Cancer Institute, Milan: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• University of Cape Town: collaborator

Study Sites (7)

Stanford Otolaryngology - Head & Neck Surgery Department

Stanford, California, 94305, United States

NOT YET RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Department of Otorhinolaryngology Head and Neck Surgery

Aarhus, 8200, Denmark

RECRUITING

Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Istituto Nazionale Tumori of Milan

Milan, 20133, Italy

NOT YET RECRUITING

Groote Schuur

Cape Town, 7935, South Africa

NOT YET RECRUITING

Karolinska Institute

Stockholm, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Tongue Neoplasms; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Daniel J Lauritzen, MD

CONTACT

+4541817574; daniel.julius.lauritzen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Ass. Prof.

Model Details: Patients will randomized to either 1)standard treatment for oral cancer 2) standard treatment for oral cancer + the use of ultrasound during surgery to guide resection process and evaluate resections margins.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact daniel.julius.lauritzen@regionh.dk

Locations

DK (2); IT (1); US (2); ZA (1); SE (1)