The objective of this feasibility study is to evaluate the clinical accuracy of an in*house developed electromagnetic (EM) navigation system in determining adequate resection margins during surgery for malignant oral cavity tumors and specifically…
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of pointing to landmarks, these measurements will result in outcomes
where an accuracy in mm will be provided.
Secondary outcome
- assessment of the potential benefit of the navigation system in terms of
optimizing resection planes
- the assessment of the feasibility of intra-operative XperCT imaging to
preoperative images of the oral cavity for maxilla and mandible patients, and
3D US for tongue patients.
- evaluation of the intuitiveness of the newly introduced technique.
Background summary
Head and neck surgeons operate on a fine edge between radical resection of
tumors and sparing of vital structures (e.g., arteries and nerves), visible
only on specific preoperative scans (CT/MR). Identification of deep tumor
margins inside the tongue is currently based on palpation and
experience/expertise of the surgeon because reliable quantitative feedback is
lacking. As a result positive and suboptimal resections are common. By means of
image-guided surgery, we can navigate the procedure by visualizing
pre-operative planned MR and/or CT based 3D models and providing the surgeon
with real-time feedback on the position of the surgical tool within this model
and more important relative to the tumor margins. These innovations may allow
to reduce both irradical resections and morbidity. This is the first study to
use MR-based three-dimensional (3D) models of surgical resections for
intra-operative navigation in head and neck surgery.
Study objective
The objective of this feasibility study is to evaluate the clinical accuracy of
an in*house developed electromagnetic (EM) navigation system in determining
adequate resection margins during surgery for malignant oral cavity tumors and
specifically tongue tumors. Ultimately we aim for an error of less than 5 mm in
80% of the completed procedures. In this phase the study will be counted
successful if it can be proven that the navigation system is accurate for at
least 60% of the completed procedures.
Study design
A feasibility study
Study burden and risks
No expected risks next to the additional radiation dose for the included
patients are expected. A similar approach for abdominal surgery was evaluated
in 50 patients (N13NAV) and no potential risks for patients were identified
during the course of the study. The only task that will change is a maximal 30
minute delay in the surgery time necessary to perform intraoperative imaging
(XperCT/US scan) and accuracy measurements.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Age * 18
- Patients planned for surgery of tumors fixated to the maxilla or mandible and patients with tongue tumors(tumor size > T1)
- Treatment plan approved by the head and neck multidisciplinary oncology meeting
- Patients Provide written *informed consent*
Exclusion criteria
- Metal implants in the neck area that could disturb EM field, influence EM tracking or jeopardize image quality of XperCT images.
- non-palpable tongue tumor
- Pacemaker
Design
Recruitment
Medical products/devices used
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 | NL60004.031.17 |