Safety and feasibility of the use of cryoablation in patients with brain neoplasm

Safety and feasibility of the use of cryoablation in patients with brain neoplasm - Cryoablation of brain neoplasm

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53649

Enrollment

Registered

2023-07-31

Start date

2023-07-30

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain neoplasm brain tumors

Interventions

See study design

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Secondary

Measure	Time frame
The secondary parameter: • The conformation of dead tumor cells by pathologist which have been cryoablated during surgery • The confirmation of reaching macroscopic tumor edges using intraoperative ultrasound (YES/NO). Pictures in 2 directions of the ultrasound will be made to objectify • The progression free survival during the entire study period (3 months) • Overall survival during the entire study period (3 months) • Progression free survival and overall survival of the different tumors will be compared to matched historic controls • Safety and feasibility will be compared to historic matched controls	—

Measure

Time frame

The secondary parameter: • The conformation of dead tumor cells by pathologist which have been cryoablated during surgery • The confirmation of reaching macroscopic tumor edges using intraoperative ultrasound (YES/NO). Pictures in 2 directions of the ultrasound will be made to objectify • The progression free survival during the entire study period (3 months) • Overall survival during the entire study period (3 months) • Progression free survival and overall survival of the different tumors will be compared to matched historic controls • Safety and feasibility will be compared to historic matched controls

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Primary

Measure	Time frame
The primary outcome is to assess the safety and feasibility of cryoablation in patients with brain neoplasm. Safety will be expressed in terms of severity and frequency of the following complications: postoperative intracranial bleeding, wound infection, epilepsy, brain edema, neurological deficit, and aphasia. The feasibility will be expressed in terms of operation time (in minutes), blood loss during the intervention (in milliliters), and practicability. Technical failures during intervention will also be investigated.	—

Measure

Time frame

The primary outcome is to assess the safety and feasibility of cryoablation in patients with brain neoplasm. Safety will be expressed in terms of severity and frequency of the following complications: postoperative intracranial bleeding, wound infection, epilepsy, brain edema, neurological deficit, and aphasia. The feasibility will be expressed in terms of operation time (in minutes), blood loss during the intervention (in milliliters), and practicability. Technical failures during intervention will also be investigated.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)