Use of Ultrasound for Measuring Size of Oral Tongue Cancers

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Brief Title

Use of Ultrasound for Measuring Size of Oral Tongue Cancers

Official Title

Use of Transoral Ultrasound for Measuring Depth Of Invasion in Oral Tongue Carcinoma, and Comparing Obtained Measurements With Measurements From MRI With the Results Obtained From Pathological Examination of Surgically Resected Specimens

Brief Summary

      The purpose of this study is to investigate the use intraoral ultrasound for measuring depth
      of invasion (DOI) in oral tongue squamous cell carcinoma. The DOI's measured on ultrasound
      and measurements from MRI scans, will be compared to the measurements made from pathological
      examination of removed specimens.
    

Detailed Description

      We will conduct a prospective cohort study to investigate the correlation between DOI
      measurements from preoperative imaging (MRI and intraoral ultrasound), and final
      histopathology findings.

      All patients with oral tongue cancer histologically verified on biopsy diagnosed in the
      Capital Region and Zealand Region (population 2.6 mio) are treated at the department of Head
      and Neck surgery at Copenhagen University Hospital (Rigshospitalet). These patients will be
      invited to participate in the study before or at their multidisciplinary team (MDT)
      conference at Rigshospitalet where the final treatment will be decided.

      The ultrasound exam is conducted with a bk5000 or bk3000 machine, a "Hockey Stick" X18L5s
      transducer or a 18L5s Linear transducer.

      The transducer will be placed directly on the tongue tumor. The tumor size will be measured,
      and depth of invasion will be estimated. For later reevaluation of the ultrasound images, a
      sweep will be performed, and image files and video clips will be stored for documentation.

      Patients will primarily be examined in the outpatient clinic, and the measurement will be
      repeated at the time of surgery when the patient is in general anesthesia. It is, however, at
      time of the examination outpatient clinic that the information about DOI is most useful in
      planning the treatment, and therefore this is measurement we will be focusing on.

      Each MRI scan will be reviewed by a radiologist and the DOI will be assessed if possible.
      According to the AJCC Cancer Staging System, 8th edition, "DOI is measured by first finding
      the 'horizon' of the basement membrane of the adjacent squamous mucosa. A perpendicular
      'plumb line' is established from this horizon to the deepest point of tumor invasion" [AJCC ]

      We aim to include 30 Patients in this study. The annual number of patients in our clinic
      operated for oral tongue carcinoma is around 50, so we aim to include the 30 patients within
      one year.
    


Study Type

Interventional


Primary Outcome

Correlation of DOI measured on ultrasound and on MRI compared to pathological examination


Condition

Tongue SCC

Intervention

Transoral ultrasound of tongue tumors

Study Arms / Comparison Groups

 Ultrasound for measuring DOI in tongue tumors
Description:  All patients included with tongue carcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

30

Start Date

October 15, 2020

Completion Date

December 2021

Primary Completion Date

August 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with squamous cell carcinoma on the lateral tongue

        Exclusion Criteria:

          -  Patients with tumor elsewhere in the oral cavity
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mikkel Kaltoft, MD, +45 35457871, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04614896

Organization ID

Ultrasoundfortonguetumors


Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark


Study Sponsor

Mikkel Kaltoft, MD, Principal Investigator, Consultant


Verification Date

October 2020