Personalisation of a biomechanical tongue model for the prediction of treatment outcome.

Personalisation of a biomechanical tongue model for the prediction of treatment outcome. - Personalisation of a biomechanical tongue model.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45672

Enrollment

Registered

2017-04-18

Start date

2017-12-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tongue cancer

Interventions

Biomechanical tongue model

Functional inoperabel

Tongue cancer

Virtual Therapy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Primary tongue or tongue base cancer (T1-T3). Primary surgery or chemoradiation treatment. Older than 18 years Informed consent

Exclusion criteria

Exclusion criteria: Previous history of oral or oropharyngeal cancer Recurrent or residual tongue/tongue base cancer Patients that are not eligible for MRI

Design outcomes

Primary

Measure	Time frame
A personalized prediction of functional consequences after treatment using a biomechanical model of the tongue and tongue base.	—

Secondary

Measure	Time frame
Range of motion endpoints * Range of tongue motion before and after operation. * Additional questionnaires regarding tongue function ( appendix) * Tongue muscle strength (IOPI) before intervention * Tongue muscle strength (IOPI) after intervention Elastography endpoints * Elasticity of tongue tissue before intervention * Elasticity of scar tissue / irradiated tissue MRI endpoints * Tongue muscular anatomy before and after partial glossectomy * Tongue functionality before and after partial glossectomy Resection profile endpoints * Dimensions of the resection intraoperatively. * Dimensions of the specimen.	—

Measure

Time frame

Range of motion endpoints * Range of tongue motion before and after operation. * Additional questionnaires regarding tongue function ( appendix) * Tongue muscle strength (IOPI) before intervention * Tongue muscle strength (IOPI) after intervention Elastography endpoints * Elasticity of tongue tissue before intervention * Elasticity of scar tissue / irradiated tissue MRI endpoints * Tongue muscular anatomy before and after partial glossectomy * Tongue functionality before and after partial glossectomy Resection profile endpoints * Dimensions of the resection intraoperatively. * Dimensions of the specimen.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)