GliomaPIONEERNCT06617208
Pilot IntraOperative Neuronal Electrophysiology in Tumor rElatEd suRgery
A study testing Neuropixel probe recording in people with Glioma and Glioblastoma (GBM), run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
INTRODUCTION AND RATIONALE Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue, disrupting normal neuronal activities and leading to impaired motor and cognitive functions, as well as causing epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma (GBM), Brain Tumor-Glioma
- What is being tested?
- Neuropixel probe recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2026to 1 Jan 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 yrs old with radiologically diagnosed brain tumor, suspect for glioma and/or metastasis.
- Eligible for surgical resection or biopsy procedure according to standard practice.
- Written Informed consent.
- Able to undergo intra-operative neuromonitoring.
Who cannot join
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, or severe treatment-resistant depression)
- Previous brain tumour surgery or radiotherapy.
- Patient has pacemaker or other implanted electrical device such as vagal nerve stimulator or other.
- Inability to give consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arnaud Vincent, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC, Department of Neurosurgery
Rotterdam, South Holland, 3015GD
Koen van der Kuil, MSc., +31 10 703 5993, k.vanderkuil@erasmusmc.nl
About this study
Official title: Pilot IntraOperative Neuronal Electrophysiology in Tumor rElatEd suRgery (PIONEER Study)
INTRODUCTION AND RATIONALE
Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue, disrupting normal neuronal activities and leading to impaired motor and cognitive functions, as well as causing epilepsy. This malignant brain tumor is considered one of the most challenging cancers to treat, with a median survival of 12 to 15 months. Recent findings on direct neuron-tumor interactions indicate that abnormal brain activity in the regions surrounding brain tumours may contribute to develop epilepsy and accelerating tumor growth. Tumors tend to 'fuel' themselves with neurotransmitters released during its 'daily' neuronal firing. Hyperactive neurons in the peritumoral cortex can form excitatory electrochemical synapses with surrounding tumor cells, creating direct communication pathways within the peritumoral microenvironment, which aids in the progression and proliferation of tumor cells via direct and paracrine signalling pathways. However, the specific features of this abnormal brain activity in the peritumoral cortex have not been fully clarified and information on the pathological changes of neuronal activity in glioma patients is largely lacking. To advance more effective treatment strategies, it is crucial to better understand the complex interactions between the tumor and the brain.
Read more
This is especially important for our group of patients of which many perceive diminished quality of life because of epilepsy, cognitive functioning and language problems after tumor surgery. Furthermore, we lack thorough understanding of what tumor resection does to the original hyperactive peritumoral cortex and if resecting this is beneficial for improving postoperative outcome both for epilepsy as well as regarding survival. Therefore, identifying the hyperactive peritumoral cortex and directly addressing its impacts on the brain function and long-term surgical outcome could be a promising novel therapeutic strategy for treating glioma patients.
STUDY AIM
Our measurement focuses on capturing neuronal activity at single-neuron resolution in the peritumoral cortex of glioma patients using cortical depth electrodes. It is well-established that gliomas can remodel the surrounding brain tissue, leading to abnormal neuronal hyperactivity, which contributes to tumor progression and epilepsy. However, the specific neuronal patterns and underlying mechanisms of these changes are not yet fully understood. Our study will aim to collect detailed single-neuron recordings in this context, enabling us to map the precise neurophysiological disruptions caused by gliomas. On the long term, our research could lay the groundwork in identifying novel therapeutic approaches by providing critical in-sights into how gliomas alter brain function.
Read the detailed description
In this study, patients with a brain tumour who undergo (awake) surgical resection as part of standard clinical care will be included. All patients who undergo such a procedure at Erasmus MC within a five-year period will be invited to participate. Based on historical case numbers, we aim to include ten patients with successful recordings during this timeframe.
The surgical procedure itself will be performed entirely according to standard clinical protocols; the surgery is not part of the research intervention. Neurological functioning will be assessed pre- and postoperatively as part of routine care. Participation in the study concludes at the end of the surgical procedure. All other procedures outside the research recordings are likewise performed within standard care.
- Conditions
- Glioma, Glioblastoma (GBM), Brain Tumor-Glioma, Brain Metastasis
- Being tested
- Neuropixel probe recording
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropixel probe recordingDevice
Also called laminar electrophysiology, cortical depth electrophysiology
Neuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex.
| Study group | Role | What they receive |
|---|---|---|
| Neuropixel probe recording | Experimental | Cortical electrophysiology using the Neuropixel probe is performed to record brain activity in the peritumoral cortex Receives: Device: Neuropixel probe recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Successful Intraoperative Neuropixels Probe Recording
Feasibility is reported as the number (and percentage) of enrolled participants in whom a successful Neuropixels probe recording is obtained. A recording is counted as successful when (1) the probe is inserted into the peritumoral cortex as planned, (2) neural data are acquired during surgery with at least one isolated single neuron after spike sorting, and (3) no device-related complications occur (retained probe fragments, infection, or hemorrhage). Reasons for unsuccessful recordings are documented in the case report form.
Measured: From the beginning of surgery until hospital discharge
Secondary outcomes (1)
Number of Isolated Single Neurons per Participant Recorded in Peritumoral Cortex
To assess whether intraoperative single-cell recordings are suitable for identifying prognostic biomarkers of disease progression, the number of single neurons isolated per participant is counted after spike sorting of the Neuropixels data. Only units that meet the predefined spike-sorting quality criteria are counted. Results are summarized as median (range) across participants. For each isolated neuron, the firing rate (spikes per second) and waveform characteristics are also reported descriptively.
Measured: From the beginning to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies 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
- Device feasibility
- 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
- Responsible party
- Principal investigator, Koen van der Kuil, Erasmus Medical Center
- Investigators
- Arnaud Vincent, Prof. dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617208
- Sponsor's protocol ID
- PaNaMa 12744
- Acronym
- PIONEER
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coughlin B, Munoz W, Kfir Y, Young MJ, Meszena D, Jamali M, Caprara I, Hardstone R, Khanna A, Mustroph ML, Trautmann EM, Windolf C, Varol E, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Mark Richardson R, Williams ZM, Cash SS, Paulk AC. Modified Neuropixels probes for recording human neurophysiology in the operating room. Nat Protoc. 2023 Oct;18(10):2927-2953. doi: 10.1038/s41596-023-00871-2. Epub 2023 Sep 11.
PubMed 37697108Paulk AC, Kfir Y, Khanna AR, Mustroph ML, Trautmann EM, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Richardson RM, Williams ZM, Cash SS. Large-scale neural recordings with single neuron resolution using Neuropixels probes in human cortex. Nat Neurosci. 2022 Feb;25(2):252-263. doi: 10.1038/s41593-021-00997-0. Epub 2022 Jan 31.
PubMed 35102333Chung JE, Sellers KK, Leonard MK, Gwilliams L, Xu D, Dougherty ME, Kharazia V, Metzger SL, Welkenhuysen M, Dutta B, Chang EF. High-density single-unit human cortical recordings using the Neuropixels probe. Neuron. 2022 Aug 3;110(15):2409-2421.e3. doi: 10.1016/j.neuron.2022.05.007. Epub 2022 Jun 8.
PubMed 35679860Leonard MK, Gwilliams L, Sellers KK, Chung JE, Xu D, Mischler G, Mesgarani N, Welkenhuysen M, Dutta B, Chang EF. Large-scale single-neuron speech sound encoding across the depth of human cortex. Nature. 2024 Feb;626(7999):593-602. doi: 10.1038/s41586-023-06839-2. Epub 2023 Dec 13.
PubMed 38093008Krishna S, Choudhury A, Keough MB, Seo K, Ni L, Kakaizada S, Lee A, Aabedi A, Popova G, Lipkin B, Cao C, Nava Gonzales C, Sudharshan R, Egladyous A, Almeida N, Zhang Y, Molinaro AM, Venkatesh HS, Daniel AGS, Shamardani K, Hyer J, Chang EF, Findlay A, Phillips JJ, Nagarajan S, Raleigh DR, Brang D, Monje M, Hervey-Jumper SL. Glioblastoma remodelling of human neural circuits decreases survival. Nature. 2023 May;617(7961):599-607. doi: 10.1038/s41586-023-06036-1. Epub 2023 May 3.
PubMed 37138086Venkataramani V, Yang Y, Schubert MC, Reyhan E, Tetzlaff SK, Wissmann N, Botz M, Soyka SJ, Beretta CA, Pramatarov RL, Fankhauser L, Garofano L, Freudenberg A, Wagner J, Tanev DI, Ratliff M, Xie R, Kessler T, Hoffmann DC, Hai L, Dorflinger Y, Hoppe S, Yabo YA, Golebiewska A, Niclou SP, Sahm F, Lasorella A, Slowik M, Doring L, Iavarone A, Wick W, Kuner T, Winkler F. Glioblastoma hijacks neuronal mechanisms for brain invasion. Cell. 2022 Aug 4;185(16):2899-2917.e31. doi: 10.1016/j.cell.2022.06.054. Epub 2022 Jul 31.
PubMed 35914528Venkataramani V, Tanev DI, Strahle C, Studier-Fischer A, Fankhauser L, Kessler T, Korber C, Kardorff M, Ratliff M, Xie R, Horstmann H, Messer M, Paik SP, Knabbe J, Sahm F, Kurz FT, Acikgoz AA, Herrmannsdorfer F, Agarwal A, Bergles DE, Chalmers A, Miletic H, Turcan S, Mawrin C, Hanggi D, Liu HK, Wick W, Winkler F, Kuner T. Glutamatergic synaptic input to glioma cells drives brain tumour progression. Nature. 2019 Sep;573(7775):532-538. doi: 10.1038/s41586-019-1564-x. Epub 2019 Sep 18.
PubMed 31534219
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot IntraOperative Neuronal Electrophysiology in Tumor rElatEd suRgery (PIONEER Study)
- ClinicalTrials.gov ID
- NCT06617208
- Acronym / sponsor ID
- PIONEER / PaNaMa 12744
- Conditions
- Glioma, Glioblastoma (GBM), Brain Tumor-Glioma, Brain Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 27 Sep 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.
INTRODUCTION AND RATIONALE
Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue, disrupting normal neuronal activities and leading to impaired motor and cognitive functions, as well as causing epilepsy. This malignant brain tumor is considered one of the most challenging cancers to treat, with a median survival of 12 to 15 months. Recent findings on direct neuron-tumor interactions indicate that abnormal brain activity in the regions surrounding brain tumours may contribute to develop epilepsy and accelerating tumor growth. Tumors tend to 'fuel' themselves with neurotransmitters released during its 'daily' neuronal firing. Hyperactive neurons in the peritumoral cortex can form excitatory electrochemical synapses with surrounding tumor cells, creating direct communication pathways within the peritumoral microenvironment, which aids in the progression and proliferation of tumor cells via direct and paracrine signalling pathways. However, the specific features of this abnormal brain activity in the peritumoral cortex have not been fully clarified and information on the pathological changes of neuronal activity in glioma patients is largely lacking. To advance more effective treatment strategies, it is crucial to better understand the complex interactions between the tumor and the brain.
This is especially important for our group of patients of which many perceive diminished quality of life because of epilepsy, cognitive functioning and language problems after tumor surgery. Furthermore, we lack thorough understanding of what tumor resection does to the original hyperactive peritumoral cortex and if resecting this is beneficial for improving postoperative outcome both for epilepsy as well as regarding survival. Therefore, identifying the hyperactive peritumoral cortex and directly addressing its impacts on the brain function and long-term surgical outcome could be a promising novel therapeutic strategy for treating glioma patients.
STUDY AIM
Our measurement focuses on capturing neuronal activity at single-neuron resolution in the peritumoral cortex of glioma patients using cortical depth electrodes. It is well-established that gliomas can remodel the surrounding brain tissue, leading to abnormal neuronal hyperactivity, which contributes to tumor progression and epilepsy. However, the specific neuronal patterns and underlying mechanisms of these changes are not yet fully understood. Our study will aim to collect detailed single-neuron recordings in this context, enabling us to map the precise neurophysiological disruptions caused by gliomas. On the long term, our research could lay the groundwork in identifying novel therapeutic approaches by providing critical in-sights into how gliomas alter brain function.
Detailed description
In this study, patients with a brain tumour who undergo (awake) surgical resection as part of standard clinical care will be included. All patients who undergo such a procedure at Erasmus MC within a five-year period will be invited to participate. Based on historical case numbers, we aim to include ten patients with successful recordings during this timeframe.
The surgical procedure itself will be performed entirely according to standard clinical protocols; the surgery is not part of the research intervention. Neurological functioning will be assessed pre- and postoperatively as part of routine care. Participation in the study concludes at the end of the surgical procedure. All other procedures outside the research recordings are likewise performed within standard care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropixel probe recording | Experimental | Device: Neuropixel probe recordingCortical electrophysiology using the Neuropixel probe is performed to record brain activity in the peritumoral cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 yrs old with radiologically diagnosed brain tumor, suspect for glioma and/or metastasis.
- Eligible for surgical resection or biopsy procedure according to standard practice.
- Written Informed consent.
- Able to undergo intra-operative neuromonitoring.
Key exclusion criteria (4 listed)
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, or severe treatment-resistant depression)
- Previous brain tumour surgery or radiotherapy.
- Patient has pacemaker or other implanted electrical device such as vagal nerve stimulator or other.
- Inability to give consent.
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 |
|---|---|---|
| Neuropixel probe recordingAlso: laminar electrophysiology, cortical depth electrophysiologyNeuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex. | Device | Neuropixel probe recording |
Primary outcome
Number of Participants With a Successful Intraoperative Neuropixels Probe Recording
Time frame: From the beginning of surgery until hospital discharge
Feasibility is reported as the number (and percentage) of enrolled participants in whom a successful Neuropixels probe recording is obtained. A recording is counted as successful when (1) the probe is inserted into the peritumoral cortex as planned, (2) neural data are acquired during surgery with at least one isolated single neuron after spike sorting, and (3) no device-related complications occur (retained probe fragments, infection, or hemorrhage). Reasons for unsuccessful recordings are documented in the case report form.
1 secondary outcome
Number of Isolated Single Neurons per Participant Recorded in Peritumoral Cortex
Time frame: From the beginning to end of surgery
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 5 Oct 2026.
- Background: PubMed 37697108Coughlin B, Munoz W, Kfir Y, Young MJ, Meszena D, Jamali M, Caprara I, Hardstone R, Khanna A, Mustroph ML, Trautmann EM, Windolf C, Varol E, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Mark Richardson R, Williams ZM, Cash SS, Paulk AC. Modified Neuropixels probes for recording human neurophysiology in the operating room. Nat Protoc. 2023 Oct;18(10):2927-2953. doi: 10.1038/s41596-023-00871-2. Epub 2023 Sep 11.
- Background: PubMed 35102333Paulk AC, Kfir Y, Khanna AR, Mustroph ML, Trautmann EM, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Richardson RM, Williams ZM, Cash SS. Large-scale neural recordings with single neuron resolution using Neuropixels probes in human cortex. Nat Neurosci. 2022 Feb;25(2):252-263. doi: 10.1038/s41593-021-00997-0. Epub 2022 Jan 31.
- Background: PubMed 35679860Chung JE, Sellers KK, Leonard MK, Gwilliams L, Xu D, Dougherty ME, Kharazia V, Metzger SL, Welkenhuysen M, Dutta B, Chang EF. High-density single-unit human cortical recordings using the Neuropixels probe. Neuron. 2022 Aug 3;110(15):2409-2421.e3. doi: 10.1016/j.neuron.2022.05.007. Epub 2022 Jun 8.
- Background: PubMed 38093008Leonard MK, Gwilliams L, Sellers KK, Chung JE, Xu D, Mischler G, Mesgarani N, Welkenhuysen M, Dutta B, Chang EF. Large-scale single-neuron speech sound encoding across the depth of human cortex. Nature. 2024 Feb;626(7999):593-602. doi: 10.1038/s41586-023-06839-2. Epub 2023 Dec 13.
- Background: PubMed 37138086Krishna S, Choudhury A, Keough MB, Seo K, Ni L, Kakaizada S, Lee A, Aabedi A, Popova G, Lipkin B, Cao C, Nava Gonzales C, Sudharshan R, Egladyous A, Almeida N, Zhang Y, Molinaro AM, Venkatesh HS, Daniel AGS, Shamardani K, Hyer J, Chang EF, Findlay A, Phillips JJ, Nagarajan S, Raleigh DR, Brang D, Monje M, Hervey-Jumper SL. Glioblastoma remodelling of human neural circuits decreases survival. Nature. 2023 May;617(7961):599-607. doi: 10.1038/s41586-023-06036-1. Epub 2023 May 3.
- Background: PubMed 35914528Venkataramani V, Yang Y, Schubert MC, Reyhan E, Tetzlaff SK, Wissmann N, Botz M, Soyka SJ, Beretta CA, Pramatarov RL, Fankhauser L, Garofano L, Freudenberg A, Wagner J, Tanev DI, Ratliff M, Xie R, Kessler T, Hoffmann DC, Hai L, Dorflinger Y, Hoppe S, Yabo YA, Golebiewska A, Niclou SP, Sahm F, Lasorella A, Slowik M, Doring L, Iavarone A, Wick W, Kuner T, Winkler F. Glioblastoma hijacks neuronal mechanisms for brain invasion. Cell. 2022 Aug 4;185(16):2899-2917.e31. doi: 10.1016/j.cell.2022.06.054. Epub 2022 Jul 31.
- Background: PubMed 31534219Venkataramani V, Tanev DI, Strahle C, Studier-Fischer A, Fankhauser L, Kessler T, Korber C, Kardorff M, Ratliff M, Xie R, Horstmann H, Messer M, Paik SP, Knabbe J, Sahm F, Kurz FT, Acikgoz AA, Herrmannsdorfer F, Agarwal A, Bergles DE, Chalmers A, Miletic H, Turcan S, Mawrin C, Hanggi D, Liu HK, Wick W, Winkler F, Kuner T. Glutamatergic synaptic input to glioma cells drives brain tumour progression. Nature. 2019 Sep;573(7775):532-538. doi: 10.1038/s41586-019-1564-x. Epub 2019 Sep 18.
- Individual participant dataSharing planned: Undecided
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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 contact
Arnaud Vincent, Prof. dr. 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 Neuropixel probe recording in people with Glioma and Glioblastoma (GBM), 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
Contact Koen van der Kuil (+31641078801, k.vanderkuil@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Successful Intraoperative Neuropixels Probe Recording (time frame: From the beginning of surgery until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617208, which also lists 7 linked publications.
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 5 Oct 2026.