Intraoperative control of maxillary malignancy resection with cone-beam computed tomography
Completed
- Conditions
- maxillary cancerupper jaw malignant tumor10019190
- Registration Number
- NL-OMON43222
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
* Primary tumours of the maxilla (T1-T4a for non-melanomas and T3-T4a for melanomas), confirmed by biopsy. Recurrent cases are also eligible.
* Any lymph node status
* M0 status
* Treatment plan approved by the multidisciplinary Head and Neck oncology meeting of the AvL
* Age over 18-years old
* No contraindications to general anesthesia
* Informed consent, written and signed
Exclusion Criteria
* Unresectable tumours of the maxillary sinus
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Technical feasibility of determining and marking of the planned treatment<br /><br>volume in the preoperative MRI.<br /><br>* Technical feasibility of obtaining intraoperative CBCT of the maxilla.<br /><br>* Assessment of the quality of matching (CBCT and MRI) by using the *Sorensen-<br /><br>Dice coefficient* and *Hausdorff distance*.<br /><br>* Rate of complete resection achieved compared to the preoperatively planned<br /><br>treatment volume. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>