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.
- Conditions
- Intracraniële laesies verwezen voor contrastverbeterde MRI van de hersenencontrast mediumintracranial lesions
- Registration Number
- NL-OMON54381
- Lead Sponsor
- Bracco Imaging S.pA.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
• 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.
• 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
within 30 days before admission into the present study, through the 7 days
post-administration of B26826; • Suffers from mild-to-severe chronic kidney
disease (estimated glomerular filtration rate < 60 mL/min/1.73 m2
calculating using the abbreviated MDRD formula); • Has, in the previous 7 days
before the first MRI with Gadovist® (0.1 mmolGd/kg) through B26826
administration, received prescription or non-prescription systemic medications
(e.g., anticancer drugs, barbiturates, or phenothiazines) which, in the opinion
of the Investigator, may interfere with the study procedure or affect safety
and efficacy assessments; • Has received or are scheduled for one of the
following: • Surgical, radiation or chemotherapeutic treatment within one weeks
prior to the first examination or between the two examinations; • initiation of
steroid therapy between the two examinations; • Has any contraindications to
MRI such as a pacemaker, magnetic material (i.e., surgical clips) or any other
conditions that would preclude proximity to a strong magnetic field • Are
suffering from severe claustrophobia; • Has participated in a clinical trial of
an investigational drug and/or medical device within 3 months before admission
into this study; • Has any medical condition or other circumstances which would
significantly decrease the chances of obtaining reliable data, achieving study
objectives, or completing the study and/or post-dose follow-up examinations; •
Cannot reliably communicate with the Investigator or is not likely to
co-operate with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method