Use of Ultrasound for Measuring Size of Oral Tongue Cancers
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators 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 the investigators 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 ]
The investigators 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 the investigators aim to include the 30 patients within one year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet Copenhagen University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with squamous cell carcinoma on the lateral tongue
Exclusion Criteria:
- Patients with tumor elsewhere in the oral cavity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Ultrasound for measuring DOI in tongue tumors
All patients included with tongue carcinoma
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A transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Measurement of DOI in millimeters
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when pathological examination is made, within 4 weeks of US and MRi
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mikkel Kaltoft, MD, Consultant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ultrasoundfortonguetumors
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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