Evaluation of Ultrahigh-Field-MRI at 7 Tesla for Imaging of ischemic lesions, carotid plaque morphology and brain perfusion - 7 UP
Organizational Data
- DRKS-ID:
- DRKS00003193
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2011-08-12
- Last update in DRKS:
- 2012-05-10
- Registration type:
- Prospective
Acronym/abbreviation of the study
7-UP
URL of the study
No Entry
Brief summary in lay language
The project 7-UP (7 Tesla Ultrahighfield Project) is a pilot study to investigate magnetic resonance imaging (MRI) at 7 Tesla ultrahigh field (UHF) in neurological disease. Compared with the highest available clinical standard with a field strength of 3 Tesla, potential benefits of the higher field strength at 7 Tesla for the diagnosis and therapeutic decision making in disease of the brain and brain supplying blood-vessels will be studied. The potential higher resolution achieved at 7 Tesla may help to depict disturbances of brain blood supply more frequently and in more detail, to assess constricted blood vessels better and to evaluate the blood flow in the brain more accurately. For this purpose, patients after disturbances of brain blood supply (stroke) and with constricted brain supplying blood vessels will be investigated. The study consists of two sessions of magnetic resonance imaging, one at 3 Tesla and another at 7 Tesla.
Brief summary in scientific language
The availability of human ultrahigh-field-magnetic resonance imaging (UHF-MRI) at 7 Tesla opens new possibilities for imaging in neuroscience. It allows for the non-invasive depiction of brain anatomy and pathology with unprecedented resolution: it was shown recently that cavernous hemangiomas could be shown in higher frequency than at 1.5 Tesla; in time-of-flight (TOF)-angiography, more 2nd and 3rd order branches could be seen than at 1.5 or 3 Tesla. Moreover, in patients with multiple sclerosis, 7 Tesla UHF-MRI was not only suited to depict more lesions in contrast to 1.5 Tesla, but cortical lesions were shown for the first time in vivo. Against this background, 7 Tesla UHF-MRI in cerebrovascular disease will be evaluated in this study.
Health condition or problem studied
- ICD10:
- I63.9 - Cerebral infarction, unspecified
- ICD10:
- I65.2 - Occlusion and stenosis of carotid artery
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- magnetic resonance maging at 3 Tesla and 7 Tesla
Endpoints
- Primary outcome:
- part 1: Number of microinfarcts after clinically proven transient ischemic attack, identified by 7 Tesla magnetic resonance imaging (MRI) in comparison to 3 Tesla MRI part 2: Discriminability of core and cap in carotid plaques at 7 Tesla in comparison to 3 Tesla. part 3: Perfusion measurement by ASL at 7 Tesla in comparison to 3 Tesla.
- Secondary outcome:
- n.a.
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- 2011-08-17
- Actual study start date:
- 2011-08-18
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- General inclusion criteria: - Stable patient condition not requiring in-hospital treatment - Age: 18 – 80 years - Preserved ability to give informed consent - Informed consent - Legal competence Specific inclusion criteria - sub-project 1: o TIA o Cortical/sub-cortical infarcts - sub-project 2: o internal or communal carotid artery stenosis (>50%) or as shown by Doppler sonography - sub-project 3: o internal carotid artery stenosis (>70%) or occlusion as shown by Doppler sonography
Exclusion Criteria
Exclusion criteria: - cardiac pacemaker or any other magnetic implant - every kind of metallic or electro-(magnetic) implant - pregnancy and breastfeeding period - claustrophobia - chronic or episodic vertigo - diseases of the retina (e.g. retinal detachment or macula degeneration)
Addresses
Primary Sponsor
- Address:
- Charité Campus Charité MitteCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- CSB-Centrum für SchlaganfallforschungUniv.-Prof. Dr. Jan SobeskyCharitéplatz111017 BerlinGermany
- Telephone:
- 030 450 560 010
- Fax:
- 030 450 560 932
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.schlaganfallcentrum.de/
Contact for Public Queries
- Address:
- CSB-Centrum für SchlaganfallforschungUniv.-Prof. Dr. Jan SobeskyCharitéplatz111017 BerlinGermany
- Telephone:
- 030 450 560 010
- Fax:
- 030 450 560 932
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.schlaganfallcentrum.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission des Landes BerlinFehrbelliner Platz 110707 BerlinGermany
- Telephone:
- +49-30-902291220
- Fax:
- +49-30-90283383
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2010-12-13
- Ethics committee number:
- 10/0563-ZS EK 11
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2011-03-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- No Entry
- Other secondary IDs:
- 00013854 - DIMDI-Nummer
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry