Functional MRI after administration of Gd-based blood pool contrast agents

Conditions: This study aims to investigate the possibility to obtain higher functional contrast and better spatial assessment in contrast enhanced functional Magnetic Resonance Imaging (fMRI) as compared to standard fMRI methods without contrast. There are several indications for fMRI, e.g. neurosurgical planning, diagnosis of neurological diseases, prognosis in patients with lesions, rehabilitation.
MedDRA version: 9.1Level: LLTClassification code 10029820Term: Nuclear magnetic resonance imaging gadolinium-enhanced
MedDRA version: 9.1Level: LLTClassification code 10029817Term: Nuclear magnetic resonance imaging brain

Registration Number: EUCTR2007-006724-35-SE

Lead Sponsor: CMIV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

healthy subjects (equal proportion of males and females)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

left-handed subjects
subjects with contraindication for MR-safety
subjects with neurological and psychiatric diseases, including alcohol and drug abuse

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to investigate the possibility to obtain higher functional contrast in contrast enhanced functional Magnetic Resonance Imaging (fMRI) as compared to standard fMRI methods without contrast. ;Secondary Objective: This study aims to investigate the possibility to obtain better spatial assessment in contrast enhanced fMRI as compared to standard fMRI methods without contrast. ;Primary end point(s): Optimised MRI sequence with functional contrast<br>Assessment of applicability of contrast enhanced fMRI.<br><br>

Secondary Outcome Measures