Tongue SCCNCT04614896
Use of Ultrasound for Measuring Size of Oral Tongue Cancers
A study testing Transoral ultrasound of tongue tumors in people with Tongue SCC and Oral Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue SCC, Oral Cancer
- What is being tested?
- Transoral ultrasound of tongue tumors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with squamous cell carcinoma on the lateral tongue
Who cannot join
- Patients with tumor elsewhere in the oral cavity
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tongue SCC, Oral Cancer
- Being tested
- Transoral ultrasound of tongue tumors
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound for measuring DOI in tongue tumors | Experimental | All patients included with tongue carcinoma Receives: Diagnostic Test: Transoral ultrasound of tongue tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of DOI measured on ultrasound and on MRI compared to pathological examination
Measurement of DOI in millimeters
Measured: when pathological examination is made, within 4 weeks of US and MRi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Oct 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue SCCStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Kaltoft, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mikkel Kaltoft, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614896
- Sponsor's protocol ID
- Ultrasoundfortonguetumors
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04614896
- Acronym / sponsor ID
- Ultrasoundfortonguetumors
- Conditions
- Tongue SCC, Oral Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound for measuring DOI in tongue tumors | Experimental | Diagnostic Test: Transoral ultrasound of tongue tumorsAll patients included with tongue carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with squamous cell carcinoma on the lateral tongue
Key exclusion criteria (1 listed)
- Patients with tumor elsewhere in the oral cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral ultrasound of tongue tumorsA transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor | Diagnostic test | Ultrasound for measuring DOI in tongue tumors |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Kaltoft, MD principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral ultrasound of tongue tumors in people with Tongue SCC and Oral Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.