Safety and feasibility of the use of cryoablation in patients with brain neoplasm
- Conditions
- brain neoplasmbrain tumors1002765610019190
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
1. Age >18 years
2. Tumor suspected as glioma (1. Astrocytoma, IDH mutant 2. Oligodendroglioma,
IDH-mutant and 1p/19q-codeleted 3. Glioblastoma, IDH-wildtype), meningioma (WHO
gr. 1 and gr 2), or brain metastasis based on preliminary diagnosis for which
the patient will undergo surgery
3. Supratentorial or infratentorial localization
4. Safe trajectory/trajectories possible for ablation of at least 70% of the
tumor, avoiding eloquent structures
5. Karnofsky performance scale 70 or more
6. Sufficient knowledge of the Dutch language to understand the study documents
(in the judgement of the attending physician or researcher)
7. Written Informed consent
1. <18 years or >80 years
2. Tumor diameter bigger than 10 cm
3. Unsafe trajectory (eloquent structures could be damaged)
4. Pregnancy
5. Contra-indication for general anesthesia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is to assess the safety and feasibility of cryoablation in<br /><br>patients with brain neoplasm. Safety will be expressed in terms of severity and<br /><br>frequency of the following complications: postoperative intracranial bleeding,<br /><br>wound infection, epilepsy, brain edema, neurological deficit, and aphasia. The<br /><br>feasibility will be expressed in terms of operation time (in minutes), blood<br /><br>loss during the intervention (in milliliters), and practicability. Technical<br /><br>failures during intervention will also be investigated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameter:<br /><br>• The conformation of dead tumor cells by pathologist which have been<br /><br>cryoablated during surgery<br /><br>• The confirmation of reaching macroscopic tumor edges using intraoperative<br /><br>ultrasound (YES/NO). Pictures in 2 directions of the ultrasound will be made to<br /><br>objectify<br /><br>• The progression free survival during the entire study period (3 months)<br /><br>• Overall survival during the entire study period (3 months)<br /><br>• Progression free survival and overall survival of the different tumors will<br /><br>be compared to matched historic controls<br /><br>• Safety and feasibility will be compared to historic matched controls</p><br>