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non_invasive_aICP_Tumor (aICPTumor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03641443
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : September 5, 2018
Information provided by (Responsible Party):
Javier Fandino, MD, Kantonsspital Aarau

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.

Condition or disease Intervention/treatment Phase
Tumor, Brain Intracranial Pressure Increase Device: Non-invasive measurement of intracranial pressure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive Measurement of Absolute Intracranial Pressure in Patients With Mass Effective Brain Tumors
Actual Study Start Date : September 12, 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Non-invasive measurement of intracranial pressure
Patient with mass effective brain tumor that undergo non-invasive intracranial pressure measurement
Device: Non-invasive measurement of intracranial pressure
Non-invasive measurement of intracranial pressure in patients with mass effective brain Tumors

Primary Outcome Measures :
  1. non-invasive, absolute intracranial pressure (aICP) before brain tumor surgery [ Time Frame: 3 Years ]
    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 Outcome Measures :
  1. Correlation between increased aICP and clinical and radiological signs [ Time Frame: 3 Years ]
    The secondary outcome is to demonstrate correlation between increased aICP and clinical and radiological signs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03641443

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Contact: Jenny Kienzler, MD 0628385872 ext +41

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Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Jenny Kienzler, MD         
Sponsors and Collaborators
Kantonsspital Aarau
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Principal Investigator: Jenny Kienzler, MD Kantonsspital Aarau

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Responsible Party: Javier Fandino, MD, MD, Kantonsspital Aarau Identifier: NCT03641443     History of Changes
Other Study ID Numbers: aICP Tumor
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site