Brain NeoplasmNCT06753617
Cryoablation of Brain Neoplasm
A study testing Cryoablation of brain neoplasm in people with Brain Neoplasm and Brain Metastases, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study will investigate the use of safety and feasibility of cryoablation in brain tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Neoplasm, Brain Metastases, Glioma
- What is being tested?
- Cryoablation of brain neoplasm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Oct 2023to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- 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
- Supratentorial or infratentorial localization
- Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
- Karnofsky performance scale 70 or more
- Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
- Written Informed consent
Who cannot join
- <18 years or >80 years
- Tumor diameter bigger than 10 cm
- Unsafe trajectory (eloquent structures could be damaged)
- Pregnancy
- Contra-indication for general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Safety and Feasibility of the Use of Cryoablation in Patients With Brain Tumors
This study will investigate the use of safety and feasibility of cryoablation in brain tumors
Read the detailed description
Cryoablation is a therapeutic modality that employs extreme cold to induce cell necrosis in tumor tissue. While the application of cryoablation for the treatment of brain tumors remains under investigation, it has been extensively utilized in other organ systems with outcomes often surpassing those of conventional therapies.
The primary objective of this research is to evaluate the safety and feasibility of cryoablation as a treatment option for patients diagnosed with various brain tumors, including gliomas, meningiomas, and metastatic lesions. Participants enrolled in this study will first undergo standard surgical resection of the brain tumor. Prior to resection, a biopsy of the tumor will be performed to obtain a histopathological diagnosis, ensuring accurate characterization of the tumor type.
Subsequently, the tumor will undergo cryoablation utilizing cryoprobes, with a maximum of two cycles of up to 10 minutes each. The specific number and diameter of cryoprobes used will be determined by the tumor's size, aiming to achieve optimal ablation coverage. Following the removal of the cryoprobes, the tumor will be resected, and standard craniotomy closure procedures will be implemented. Patients will receive standardized postoperative care tailored to their clinical needs.
The follow-up period for this study will extend up to three months following the completion of treatment for the last enrolled participant, allowing for comprehensive assessment of treatment outcomes and safety profiles.
- Conditions
- Brain Neoplasm, Brain Metastases, Glioma, Meningioma
- Being tested
- Cryoablation of brain neoplasm
- Keywords
- Cryoablation, Cryosurgery, Brain neoplasm, Feasibility studies
- Medical subject headings
- Brain Neoplasms, Glioma, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation of brain neoplasmProcedure or surgery
The procedure begins with standard surgical exposure of the tumor, followed by a biopsy. Next, one or more cryoprobes will be positioned directly into the tumor for ablation. Once positioned, the cryoablation process will commence. A maximum of 2x10 minutes cryoablation cycles will be established followed by active thawing. Following ablation, resection of the tumor will be performed, after which patients will receive standard treatment and follow-up care. Ice formation around the cryoprobes will be monitored using intraoperative ultrasound to optimize the ablation process.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation Treatment Group | Experimental | All patients enrolled in this study will undergo cryoablation as part of their surgical tumor resection procedure. The intervention will be integrated into the standard surgical approach. Receives: Procedure: Cryoablation of brain neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and Severity of Complications and Morbidity During the Study Period
Complications \& morbidity during the entire study period as decided by the treating physician. Severity and frequency of the following complications:
- Postoperative intracranial bleeding
- Wound infection
- Epilepsy
- Brain edema
- Neurological deficit (paresis/plegia)
- Aphasia
- Death
Measured: From enrollment to the end of the study, with a minimum follow-up of 3 months. Complications such as bleeding, infection, epilepsy, brain edema, neurological deficit, and death will be evaluated, with safety assessed up to 12 months post-surgery.
Feasibility Evaluation in Operation Time
Descriptive:
Operation time (in minutes)
Measured: From start to end of the procedure, measured in minutes.
Feasibility Evaluation in Blood Loss
Descriptive:
Blood loss during intervention (in milliliters)
Measured: From start to end of the cryoablation procedure, measured in milliliters.
Secondary outcomes (3)
Assessment of Tumor Cell Ablation: percentage of patients with total resections
The percentage of patients with total resections (percentage of patients who undergo a complete tumor resection).
Measured: For progression-free survival and overall survival, the time frame is defined as the period from the date of enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Assessment of Progression-Free Survival
Progression-free survival (PFS) per patient, measured from the date of enrollment to 3 months after enrollment, assessed for disease progression or death.
Measured: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Assessment of Overall Survival
Overall Survival (OS) per patient type at 3 months, measured from the date of enrollment to 3 months after enrollment, assessed for survival (alive or deceased)
Measured: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start17 Oct 2023
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Arnaud J.P.E. VIncent, Erasmus Medical Center
- Investigators
- Arnaud Vincent, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753617
- Sponsor's protocol ID
- NL81429.078.22
- Status last verified
- Dec 2024
- First submitted
- 15 Nov 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the Use of Cryoablation in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT06753617
- Acronym / sponsor ID
- NL81429.078.22
- Conditions
- Brain Neoplasm, Brain Metastases, Glioma, Meningioma
- Keywords
- Cryoablation, Cryosurgery, Brain neoplasm, Feasibility studies
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the use of safety and feasibility of cryoablation in brain tumors
Detailed description
Cryoablation is a therapeutic modality that employs extreme cold to induce cell necrosis in tumor tissue. While the application of cryoablation for the treatment of brain tumors remains under investigation, it has been extensively utilized in other organ systems with outcomes often surpassing those of conventional therapies.
The primary objective of this research is to evaluate the safety and feasibility of cryoablation as a treatment option for patients diagnosed with various brain tumors, including gliomas, meningiomas, and metastatic lesions. Participants enrolled in this study will first undergo standard surgical resection of the brain tumor. Prior to resection, a biopsy of the tumor will be performed to obtain a histopathological diagnosis, ensuring accurate characterization of the tumor type.
Subsequently, the tumor will undergo cryoablation utilizing cryoprobes, with a maximum of two cycles of up to 10 minutes each. The specific number and diameter of cryoprobes used will be determined by the tumor's size, aiming to achieve optimal ablation coverage. Following the removal of the cryoprobes, the tumor will be resected, and standard craniotomy closure procedures will be implemented. Patients will receive standardized postoperative care tailored to their clinical needs.
The follow-up period for this study will extend up to three months following the completion of treatment for the last enrolled participant, allowing for comprehensive assessment of treatment outcomes and safety profiles.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation Treatment Group | Experimental | Procedure: Cryoablation of brain neoplasmAll patients enrolled in this study will undergo cryoablation as part of their surgical tumor resection procedure. The intervention will be integrated into the standard surgical approach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- 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
- Supratentorial or infratentorial localization
- Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
- Karnofsky performance scale 70 or more
Key exclusion criteria (5 listed)
- <18 years or >80 years
- Tumor diameter bigger than 10 cm
- Unsafe trajectory (eloquent structures could be damaged)
- Pregnancy
- Contra-indication for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation of brain neoplasmThe procedure begins with standard surgical exposure of the tumor, followed by a biopsy. Next, one or more cryoprobes will be positioned directly into the tumor for ablation. Once positioned, the cryoablation process will commence. A maximum of 2x10 minutes cryoablation cycles will be established followed by active thawing. Following ablation, resection of the tumor will be performed, after which patients will receive standard treatment and follow-up care. Ice formation around the cryoprobes will be monitored using intraoperative ultrasound to optimize the ablation process. | Procedure or surgery | Cryoablation Treatment Group |
Primary outcome
Safety: Incidence and Severity of Complications and Morbidity During the Study Period
Time frame: From enrollment to the end of the study, with a minimum follow-up of 3 months. Complications such as bleeding, infection, epilepsy, brain edema, neurological deficit, and death will be evaluated, with safety assessed up to 12 months post-surgery.
Complications \& morbidity during the entire study period as decided by the treating physician. Severity and frequency of the following complications: * Postoperative intracranial bleeding * Wound infection * Epilepsy * Brain edema * Neurological deficit (paresis/plegia) * Aphasia * Death
Feasibility Evaluation in Operation Time
Time frame: From start to end of the procedure, measured in minutes.
Descriptive: Operation time (in minutes)
Feasibility Evaluation in Blood Loss
Time frame: From start to end of the cryoablation procedure, measured in milliliters.
Descriptive: Blood loss during intervention (in milliliters)
3 secondary outcomes
Assessment of Tumor Cell Ablation: percentage of patients with total resections
Time frame: For progression-free survival and overall survival, the time frame is defined as the period from the date of enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Assessment of Progression-Free Survival
Time frame: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Assessment of Overall Survival
Time frame: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud Vincent, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation of brain neoplasm in people with Brain Neoplasm and Brain Metastases, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and Severity of Complications and Morbidity During the Study Period (time frame: From enrollment to the end of the study, with a minimum follow-up of 3 months. Complications such as bleeding, infection, epilepsy, brain edema, neurological deficit, and death will be evaluated, with safety assessed up to 12 months post-surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.