non_invasive_aICP_Tumor

NCT03641443 | Completed DMC

• 1 other identifier: aICP Tumor
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Tumor, Brain; Intracranial Pressure Increase

Outcome Measures

Primary Outcomes (1)

• non-invasive, absolute intracranial pressure (aICP) before brain tumor surgery

  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.

  3 Years

Secondary Outcomes (1)

• Correlation between increased aICP and clinical and radiological signs

  3 Years

Study Arms (1)

Non-invasive measurement of intracranial pressure

EXPERIMENTAL

Patient with mass effective brain tumor that undergo non-invasive intracranial pressure measurement

Device: Non-invasive measurement of intracranial pressure

Interventions

Non-invasive measurement of intracranial pressure DEVICE

Non-invasive measurement of intracranial pressure in patients with mass effective brain Tumors

Non-invasive measurement of intracranial pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with wounds, scars including the front orbital region.
• Patients with any known ocular condition that may be worsened by sustained eye pressure

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

MeSH Terms

Conditions

Brain Neoplasms; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jenny Kienzler, MD

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 12, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)