Sarcoma Malignant bone and soft tissue tumors
Conditions
Interventions
In Part I, patients will undergo an additional ultrasound acquisition to image the bones in the operation room, just before the surgeon starts with the procedure. Together with the preoperative derive
In Part II, all included patients will receive their standard of care treatment plan for sarcoma tumor resection. Additionally to this standard procedure, navigation will be initialized and used durin
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Part I:Age >0-17 years; Patients undergoing surgery at the Princess Maxima Center for Pediatric Oncology; Available 3D model of the bone/bones, based on the most recent PET/CT or CT, that we will use for registration. Tumor visibility is not necessary for this part;Written informed consent.Part II:Age >0-17 years;Patients undergoing surgery at the Princess Maxima Center for Pediatric Oncology; Sarcoma related primary tumors, local tumor recurrences or metastatic lymph nodes located in either the pelvic, abdominal or thoracic wall area;Pre-operative imaging is available to compute 3D models that will be used for registration and navigation. Therefore the following scans should be available;Bone: a most recent PET/CT or CT to be used for patient registration;Tumor: a most recent MRI to compute 3D models of the tumor for intraoperative navigation;Written informed consent.
Exclusion criteria
Exclusion criteria: Preoperative imaging not sufficient for preparing the 3D model as determined by the radiologist / surgeon / technical physician;Indication against inclusion by the surgeon or oncologist; An installed pacemaker, causing interference with the electromagnetic field.Additional exclusion criteria specific for Part II:Local recurrence or metastatic disease in the pleural or lung regions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In Part I, define the surface registration error. In Part II, determine the surgical feasibility of navigated surgery for pediatric pelvic, abdominal, and thoracic sarcoma surgery. The surgical feasibility comprises (i) surgical usability (i.e., a SUS-score of >70 and a proven preference for surgical navigation), (ii) surgical accuracy (=< 4 mm for the TFB-group and =< 5 mm for the FMT-group) | — |
Secondary
| Measure | Time frame |
|---|---|
| In Part I, define the most efficient sensor locations and the time it takes for the sensor placement, image acquisition and patient registration.In Part II, technical performance (i.e., technical failures, time required for the patient registration during surgery =< 10 minutes, and number of required re-registrations). | — |
Countries
Netherlands
Contacts
Public ContactA.F.W. Steeg
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed