NCT04614896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

October 28, 2020

Last Update Submit

March 28, 2023

Conditions

Tongue SCCOral Cancer

Outcome Measures

Primary Outcomes (1)

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

    Measurement of DOI in millimeters

    when pathological examination is made, within 4 weeks of US and MRi

Study Arms (1)

Ultrasound for measuring DOI in tongue tumors

EXPERIMENTAL

All patients included with tongue carcinoma

Diagnostic Test: Transoral ultrasound of tongue tumors

Interventions

Transoral ultrasound of tongue tumorsDIAGNOSTIC_TEST

A transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor

Ultrasound for measuring DOI in tongue tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with squamous cell carcinoma on the lateral tongue

You may not qualify if:

  • Patients with tumor elsewhere in the oral cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Mikkel Kaltoft, MD

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 4, 2020

Study Start

October 15, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)