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

NCT01830894 | Unknown Phase 1

• 1 other identifier: SHEBA-12-9889-SH-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• delayed peri - hemorrhage edema as a relation to early BBB disruption

  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

  1 week

Study Arms (3)

spontaneous ICH bleeding

EXPERIMENTAL

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

chronic sub dural bleeding

EXPERIMENTAL

An initial Baseline MRI is to be done at the time of diagnosis. second MRI which serves as review -within two weeks.

Device: MRI

acute sub-dural bleeding

EXPERIMENTAL

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

Interventions

MRI DEVICE

3 MRI on different times during the study for each arm.

Also known as: BBB disruption detection algorithm using Gad enhanced MR

acute sub-dural bleeding; chronic sub dural bleeding; spontaneous ICH bleeding

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center, Tel Hashomer

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sagi Harnof, MD

  Neurosurgery department, Sheba medical center, Tel Hashomer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sagi Harnof, MD

CONTACT

+972-52-6666291; Sagi.HarNof@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 12, 2013

Record last verified: 2013-03

Locations

IL (1)