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Use of Ultrasound for Measuring Size of Oral Tongue Cancers

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ClinicalTrials.gov Identifier: NCT04614896
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Mikkel Kaltoft, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tongue SCC Oral Cancer Diagnostic Test: Transoral ultrasound of tongue tumors Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound for measuring DOI in tongue tumors
All patients included with tongue carcinoma
 Diagnostic Test: Transoral ultrasound of tongue tumors
A transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of DOI measured on ultrasound and on MRI compared to pathological examination [ Time Frame: when pathological examination is made, within 4 weeks of US and MRi ]
    Measurement of DOI in millimeters


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with squamous cell carcinoma on the lateral tongue

Exclusion Criteria:

  • Patients with tumor elsewhere in the oral cavity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614896


Contacts
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Contact: Mikkel Kaltoft, MD +45 35457871 mikkel.kaltoft.01@regionh.dk
Contact: Christoffer H Hahn, MD +45 35459789 christoffer.holst.hahn.01@regionh.dk

Locations
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Denmark
Rigshospitalet Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Mikkel Kaltoft, MD    +4535457871    mikkel.kaltoft.01@regionh.dk   
Contact: Christoffer H Hahn, MD    +4535459789    christoffer.holst.hahn.01@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Mikkel Kaltoft, MD Consultant
More Information
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Responsible Party: Mikkel Kaltoft, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04614896    
Other Study ID Numbers: Ultrasoundfortonguetumors
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases