NL-OMON54381
Recruiting
Not Applicable
Safety, tolerability, efficacy and pharmacokinetic study of increasing doses of B26826 in adult patients with known or suspected intracranial lesions referred for contrast-enhanced MRI of the brain. - FIH study with a new contrast medium (B26826) for Magnetic Resonance.
Bracco Imaging S.pA.0 sites12 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracraniële laesies verwezen voor contrastverbeterde MRI van de hersenen
- Sponsor
- Bracco Imaging S.pA.
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provides written Informed Consent and is willing to comply with protocol
- •requirements;
- •Male and female between 18 and 75 years of age inclusive;
- •Is referred for and has been scheduled to undergo a contrast\-enhanced MRI
- •examination of the brain;
- •Has a Karnofsky Performance Score \>\=70\.
Exclusion Criteria
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy: • by
- •testing on site at the institution (serum βHCG) within 24 hours prior to the
- •start of Gadovist(r) administration, • by surgical history (e.g., tubal
- •ligation or hysterectomy), • post\-menopausal with a minimum 1 year without
- •menses; • Has any known allergy to GBCAs; • Have congestive heart failure
- •(class IV according to the classification of the New York Heart Association;);
- •Have suffered a stroke within a year; • Have received or are scheduled to
- •receive any other contrast medium in the 24 hours preceding Gadovist(r)
- •injection through 7 days following B26826 administration; • Have received or
- •are scheduled to receive an investigational compound and/or medical device
Outcomes
Primary Outcomes
Not specified
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