Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07203911

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Not Eligible

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.

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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

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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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