Clinical trial · Interventional
non_invasive_aICP_Tumor
Non-Invasive Measurement of Absolute Intracranial Pressure in Patients With Mass Effective Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Since decades, neurosurgeons and neurooncologists assumed that the mass effect of brain tumors with peritumoral edema or intratumoral hemorrhage might lead to increased ICP. Therefore, decisions on surgical procedures and medical treatments were made based on clinical and radiological findings suggesting increased ICP. But in fact, no measurement has ever confirmed increased ICP in brain tumor patients. From an ethical point of view, it is not justifiable to implant an intraparenchymal ICP probe within an invasive surgical procedure in a brain tumor patient unless the patient is comatose or present with rapid impairment of the level of consciousness. Therefore, with the new medical device for non-invasive ICP measurement presented in this study protocol, we will be able to measure absolute ICP values in patients with brain tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Pressure Increase | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-invasive measurement of intracranial pressure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Non-invasive measurement of intracranial pressure
- description
- Patient with mass effective brain tumor that undergo non-invasive intracranial pressure measurement
- interventionNames
- Device: Non-invasive measurement of intracranial pressure
Primary outcomes (1)
- measure
- non-invasive, absolute intracranial pressure (aICP) before brain tumor surgery
- timeFrame
- 3 Years
- description
- The primary outcome is the non-invasive, absolute intracranial pressure (aICP) before brain tumor surgery, as determined by the "NON-INVASIVE ICP ABSOLUTE VALUE METER" in mmHG.
Secondary outcomes (1)
- measure
- Correlation between increased aICP and clinical and radiological signs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with diagnosed brain tumor with signs of mass effect, occlusive hydrocephalus, and/or perilesional brain edema on CT scan or magnetic resonance imaging (MRI). * Clinical symptoms for intracranial hypertension such as headache, nausea, vomiting, neurological deficits, cognitive deficits, hemiparesis or cranial nerve deficits. * Age: ≥ 18 years at admission * Informed consent Exclusion Criteria: * Patients with wounds, scars including the front orbital region. * Patients with any known ocular condition that may be worsened by sustained eye pressure
References
Publications (0)
Data not yet available