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Feasibility Study of New MRI Protocol in Assessing Early Blood Brain Barrier Disruption (BBBD)in Related to Delay Brain Edema (BBBD)

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ClinicalTrials.gov Identifier: NCT01830894
Recruitment Status : Unknown
Verified March 2013 by Dr. Sagi Harnof, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Sagi Harnof, Sheba Medical Center

Brief Summary:

MRI research Group in the Advanced Technology Center of the Sheba Medical Center has developed an innovative methodology based on leakage (extravasation) contrast agent that allows to map the entire brain with high resolution and high sensitivity to check and describe disorders BBB (blood brain barrier).

The aim of the current study is to evaluate the feasibility of the BBB disruption detection method to predict delayed peri - hemorrhage edema.


Condition or disease Intervention/treatment Phase
Intra Cerebral Hemorrhage Device: MRI Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation and Correlation Between the Disruption in Blood-brain-barrier and the Development of Secondary Brain Edema Associated With Brain Damage by Using MRI in Patients With Various Types of Intra-cranial Bleeding
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Arm Intervention/treatment
Experimental: spontaneous ICH bleeding
An initial Baseline MRI is to be done within 6-24 hours from the bleeding. second MRI which serves as review - on the 3rd -5th day after bleeding
Device: MRI
3 MRI on different times during the study for each arm.
Other Name: BBB disruption detection algorithm using Gad enhanced MR

Experimental: chronic sub dural bleeding
An initial Baseline MRI is to be done at the time of diagnosis. second MRI which serves as review -within two weeks.
Device: MRI
3 MRI on different times during the study for each arm.
Other Name: BBB disruption detection algorithm using Gad enhanced MR

Experimental: acute sub-dural bleeding
An initial Baseline MRI is to be done within 6-24 hours from the bleeding. second MRI which serves as review - within two weeks.
Device: MRI
3 MRI on different times during the study for each arm.
Other Name: BBB disruption detection algorithm using Gad enhanced MR




Primary Outcome Measures :
  1. delayed peri - hemorrhage edema as a relation to early BBB disruption [ Time Frame: 1 week ]
    early BBB disruption will be calculated from Gad enhanced magnetic resonance (MR) and a correlation to late volume of edema as calculated using 3D methods will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-80 years.
  • patient is able to sign the informed consent form.
  • Spontaneous brain hemorrhage ICH in the last12 hours ( pre- admission,or sub- dural bleeding (whether acute or chronic ).

Exclusion Criteria:

  • The patient meets a contraindication to undergo MRI.
  • The patient is too unstable to undergo MRI
  • The patient is a candidate for surgery within 24 hours.

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 ClinicalTrials.gov identifier (NCT number): NCT01830894


Contacts
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Contact: Sagi Harnof, MD +972-52-6666291 Sagi.HarNof@sheba.health.gov.il

Locations
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Israel
Sheba medical center, Tel Hashomer Not yet recruiting
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Sagi Harnof, MD Neurosurgery department, Sheba medical center, Tel Hashomer

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Responsible Party: Dr. Sagi Harnof, M.D., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01830894     History of Changes
Other Study ID Numbers: SHEBA-12-9889-SH-CTIL
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Brain Edema
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases