CIPHER System use during brain tumor surgery
Official title: A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Run by Coherence Neuro Australia Pty Limited · NCT07465796 · Data updated 2026-11-12
A first-in-human test to see if the CIPHER System can be safely used to map and stimulate brain tissue during glioma surgery in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Coherence Neuro Australia Pty Limited Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Status | Recruiting |
| Started | May 22, 2026 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07465796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with newly diagnosed supratentorial glioma requiring open craniotomy and tumor near cortical surfaces.
✕Probably not a fit
Patients with prior craniotomy at the same location, planned awake craniotomy, seizures history, coagulation disorders, or pregnancy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This exploratory study tests the CIPHER System, a flexible, electrode-dense cortical probe, during open brain tumor removal to map functional areas and record neural activity. The main goal is to assess safety during intraoperative use, with secondary goals evaluating how well the electrodes record and respond to stimulation. Patients undergo standard-of-care tumor resection with CIPHER testing performed just before tumor removal, followed by postoperative monitoring at recovery, two weeks, and six weeks. The trial uses intraoperative electrocorticography to guide mapping and assess system handling in a real surgical setting.
Why it matters
Potential benefit: If successful, the CIPHER System could improve accuracy of functional mapping and potentially enhance tumor resection while preserving critical brain functions.
How similar studies have gone: There is emerging evidence supporting electrical stimulation and recording in brain tumor surgery, but this specific first-in-human approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed supratentorial glioma requiring resection * Glioma mass reaches or close to cortical surface * Adults aged 18-75 * Planned for open craniotomy under Total Intravenous Anesthesia (TIVA) * Patient able to provide informed consent * Performance status: Eastern Cooperative Oncology Group (ECOG) scale 0-2 Exclusion Criteria: * Prior craniotomy at the same anatomical location * Plan for awake craniotomy * Any history of seizures prior to craniotomy * Any history of coagulopathy or coagulation disorders * Pregnant status during craniotomy
Where it's running
-
The Royal Melbourne Hospital, Department of Neurosurgery 4 East
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Andrew Morokoff, MBBS PhD FRACS
- Email: morokoff@unimelb.edu.au
- Phone: +61 393 482 712
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
YN003 injection in glioma patients
This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
-
Brain connectome project in adults with brain glioma undergoing surgery
This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
-
Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas
This study tests whether proton therapy can better preserve thinking and memory than photon therapy for adults with IDH-mutated grade 2–3 gliomas who need radiation.
-
Connectome-guided network planning for brain tumor surgery in eloquent areas
This study tests whether using patient-specific brain network maps from diffusion MRI can help surgeons plan and guide brain tumor removal in eloquent areas.
-
AI-powered analysis of brain MRI to help glioma care
Doctors will use AI to study existing MRI scans and patient data from adults with glioma to see if it can help with non-invasive diagnosis and treatment planning.
-
Safusidenib in IDH1-mutant glioma after vorasidenib progression
This trial tests safusidenib in people with IDH1-mutant glioma who progressed on vorasidenib and did not need immediate chemo or radiation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.