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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:

Research's Protocol:

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 .

Research team:

Main (Primary researcher):

Sagi Harnof MD , Neurosurgery department, Sheba medical center, Tel Hashomer

Secondary researchers:

Prof. David Tanne (M.D), Neurology department .

Dr. Yael Mardor (PhD), Advanced technology department.

Dr. Oded Goren (M.D), Neurosurgery department.

Dr. Masswadeh Ahmad (M.D), Neurosurgery Department.

Background :

Spontaneous brain hemorrhage is one of the most difficult issues in strokes concept regarding underlying pathology, reasons and treatment.

Etiology:

  • General prevalence of about approximately 10-15% in all strokes.
  • Mortality and morbidity associated with it are the most severe with mortality rates of up to 50-60%.

There are various pathologies thought to be responsible for bleeding, most commonly known to be :

hypertension, Angiopathies, amyloidotic or vascular problems and space occupying lesions.

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sheba Medical Center

Dates:
Date Received: April 10, 2013
Date Started: April 2013
Date Completion: June 2014
Last Updated: April 10, 2013
Last Verified: March 2013