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

ConditionsTongue CancerOral CancerSquamous Cell Carcinoma of the Oral Cavity or Oropharynx
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTobias Todsen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age < 18 years.

Oral cancer with suspected bone involvement.

Unable to understand verbal or written information.

Prior radiotherapy treatment of oral cavity cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Treatment

    Other intervention

    Standard surgical treatment of oral cancer

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgeon prediction of final margin

Surgeons prediction of deep margin in mm

Time frame
2 weeks.

Secondary outcomes

1

Clear Margin

Clear margin rate as a dichotomous outcome (clear vs non-clear)

Time frame
2 weeks.
2

Dysphagia questionnaire

MD Anderson Dysphagia Inventory to assess dysphagia at 3 and 12 months.

Time frame
12 months
3

Cancer recurrence

This outcome will explore whether the use of ultrasound leads to more complete removal of cancerous tissue.

Time frame
24 months
4

Survial

This outcome will explore whether an expected increased frequency of "free surgical margins" in the intervention group also reflects on survival.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tobias Todsen

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Karolinska Institutet

Collaborator

National Cancer Institute, Milan

Collaborator

Aarhus University Hospital

Collaborator

Odense University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Source ClinicalTrials.gov
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