No registrations found.
ID
Source
Brief title
Health condition
Hoofdhals kanker chirurgie
Sponsors and support
Intervention
Outcome measures
Primary outcome
This feasibility study evaluates the overall performance and clinical accuracy of the surgical navigation system during surgery for malignant oral cavity tumors, without any impact on the surgical procedure itself.
The total time of the proposed intra-operative scan, including the planned accuracy measurements of the EM system, will take no longer than 30 minutes.
Secondary outcome
This feasibility study evaluates the overall performance and clinical accuracy of the surgical navigation system during surgery for malignant oral cavity tumors, without any impact on the surgical procedure itself.
The total time of the proposed intra-operative scan, including the planned accuracy measurements of the EM system, will take no longer than 30 minutes.
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 mainly 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 visualization of 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
By means of image-guided surgery, we can navigate the procedure by visualization of 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.
Study design
Yearly update
Intervention
The study includes 3 groups of tumor types, with different levels of complexity for navigation; group 1 are oral cavity carcinomas of the maxilla, group 2 are mandibular carcinomas, and group 3 are tongue carcinomas. This is to gather data, gain experience, examine feasibility, and accuracy in variations with different complexities. Prior to surgery, an CT/MR-based 3D model is constructed, containing the tumor (margins), anatomical structures, and vital structures within the area of resection. This model will be used as guidance during the surgery. At the start of the surgical procedure, electromagnetic sensors will be positioned externally on the head and, in case of mobile structures, such as the mandibular and the tongue, also at/nearby the tumor site. These EM sensors function as reference markers, which are used for intraoperative tracking. In addition, an intra operative XperCT-scan (for maxilla and mandibular patients) or an intra-operative 3D US scan (for tongue patients) of the patient will be acquired to provide a direct link between current position of the tumor and the location of the tumor and surrounding anatomy on the preoperative MR scan. Fusion of intra-operative XperCT/3D US and pre-operative MR images will allow us to visualize the exact position of the tumor within the oral cavity in an MR-based 3D model during surgery. During the surgical procedure, anatomical structures and the tumor margins can now be identified using a blunt EM-tracked probe of the navigation system.
Inclusion criteria
- Age >= 18
- Patients planned for surgery of tumors fixated to the maxilla or mandible and patients with tongue tumors
- 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
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 |
---|---|
NTR-new | NL7055 |
NTR-old | NTR7260 |
Other | NL60004.031.17 : N17TOT |