Use of Ultrasound for Measuring Size of Oral Tongue Cancers
Primary Purpose
Tongue SCC, Oral Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transoral ultrasound of tongue tumors
Sponsored by
About this trial
This is an interventional diagnostic trial for Tongue SCC
Eligibility Criteria
Inclusion Criteria:
- Patients with squamous cell carcinoma on the lateral tongue
Exclusion Criteria:
- Patients with tumor elsewhere in the oral cavity
Sites / Locations
- Rigshospitalet Copenhagen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound for measuring DOI in tongue tumors
Arm Description
All patients included with tongue carcinoma
Outcomes
Primary Outcome Measures
Correlation of DOI measured on ultrasound and on MRI compared to pathological examination
Measurement of DOI in millimeters
Secondary Outcome Measures
Full Information
NCT ID
NCT04614896
First Posted
October 28, 2020
Last Updated
March 28, 2023
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04614896
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue SCC, Oral Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound for measuring DOI in tongue tumors
Arm Type
Experimental
Arm Description
All patients included with tongue carcinoma
Intervention Type
Diagnostic Test
Intervention Name(s)
Transoral ultrasound of tongue tumors
Intervention Description
A transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor
Primary Outcome Measure Information:
Title
Correlation of DOI measured on ultrasound and on MRI compared to pathological examination
Description
Measurement of DOI in millimeters
Time Frame
when pathological examination is made, within 4 weeks of US and MRi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with squamous cell carcinoma on the lateral tongue
Exclusion Criteria:
Patients with tumor elsewhere in the oral cavity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Kaltoft, MD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Ultrasound for Measuring Size of Oral Tongue Cancers
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