The next step is to personalize the model and validate the model using different modalities. These modalities are grouped into four subprojects. Finally, the results of the subprojects will be integrated within the biomechanical model so that a…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A personalized prediction of functional consequences after treatment using a
biomechanical model of the tongue and tongue base.
Secondary outcome
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.
Background summary
Among all treatments of cancer, surgery of locally advanced head and neck
cancer has one of the highest risks of loss of vital functions. Speech,
mastication and swallowing are complex functions that are easily affected. A
systematic review on swallowing dysfunction and speech intelligibility after
oral cancer surgery demonstrated that serious swallowing deficiencies were
experienced by over 80% of patients and severe impairment of speech
intelligibility was observed in 20% of patients1. The term *functional
inoperability* is used when unacceptable function loss after surgery is to be
expected2,3. Organ-sparing chemoradiation for advanced oral cancer is used as
an alternative to surgery, but this therapy can also seriously affect vital
functions due to fibrosis and xerostomia4. The choice between these two
treatment modalities is not evidence based. In an international survey among
surgeons and radiotherapists no consensus was reached for the majority of
surgical interventions regarding functional inoperability3. Objective
counselling of patients on the expected functional outcome is therefore
currently impossible. Although severely needed, no standardized evaluation tool
exists to help predict a personalized functional outcome of oral cancer
therapies. In the project *Virtual Therapy*, we are developing such a tool for
oral cancer surgery and radiotherapy. Within the virtual therapy project
(www.virtualtherapy.nl) we are developing a biomechanical model of the oral
cavity to quantitatively predict function loss after treatment (virtual
treatment).
The past couple of years we worked on biomechanical models of the lips and oral
cavity in collaboration with the University of Twente and the University of
British Columbia, which supplied us with a framework (ArtiSynth) to create and
to edit biomechanical models (artisynth.magic.ubc.ca)5. The ArtiSynth framework
is used to develop an advanced surgical simulation tool demonstrating
postoperative movement after a partial glossectomy. click here for a video. A
comparison between the postoperative movement of the model and three patients
showed that the model was indeed able to show qualitative comparable motions6.
This model was also able to simulate impairments as a result of fibrosis which
occurs in both surgery and radiotherapy.
More details can be found in the additional protocol.
Study objective
The next step is to personalize the model and validate the model using
different modalities. These modalities are grouped into four subprojects.
Finally, the results of the subprojects will be integrated within the
biomechanical model so that a completely personalized virtual partial
glossectomy or radiotherapy treatment can be performed and the posttreatment
impairment can be simulated
Study design
Prospective cohort study / Feasibility study
Study burden and risks
During the three visits the extent of burden will be
- Visit 1: 35 minutes
- Visit 2: 65 minutes (surgery patients) or 20 minutes (radiotherapy patients)
- Visit 3: 20 minutes
None of the procedures in this study are considered to be of any physical harm
to the patient. No invasive measurements are performed.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Primary tongue or tongue base cancer (T1-T3).
Primary surgery or chemoradiation treatment.
Older than 18 years
Informed consent
Exclusion criteria
Previous history of oral or oropharyngeal cancer
Recurrent or residual tongue/tongue base cancer
Patients that are not eligible for MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60608.031.17 |