Phase IV, Double-blind, Multi-center, Randomized, Cross-over Study to Compare 0.10 mmol/kg of MultiHance R with 0.10 mmol/kg of Omniscan R in Magnetic Resonance Imaging MRI of the Brain - Crossover Comparison of MultiHance R and Omniscan R in Brain Tumors

Active, not recruiting

Conditions: patients sent to the sites with a request for assessment/diagnoses of certain/suspected brain neoplasms
MedDRA version: 6.1Level: PTClassification code 10029816

Registration Number: EUCTR2006-001680-33-IT

Lead Sponsor: BRACCO IMAGING

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 114

Inclusion Criteria

Enroll subjects in this study if they meet the following inclusion criteria Are at least 18 years of age or older; Are able to give written informed consent and are willing to comply with the protocol requirements; Are scheduled to undergo MRI; Are willing to undergo two MRI procedures within 14 days; Have confirmed or are highly suspected to have brain tumor s , as determined by at least one of the following clinical/neurological symptomatology; diagnostic testing, such as CT or previous MRI examinations from 30 days to 24 hours prior to the first MRI exam; have had recent surgery within 6 months and are to be evaluated for recurrence
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed. Are pregnant or lactating females. Exclude the possibility of pregnancy by testing on site at the institution serum or urine 61538;HCG within 24 hours prior to the start of each investigational product administration; or by history i.e., tubal ligation or hysterectomy ; or post menopausal with a minimum of 1 year without menses. Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals. 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 through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2. Have received an investigational compound and/or medical device within 30 days before admission into the present study, and/or are scheduled to 24 hours post-administration of the second investigational product. Have been previously entered into this study. Have received or are scheduled for one of the following Surgery within three weeks prior to the first examination or between the two examinations; Initiation of steroid therapy between the two examinations; Radiosurgery between the two examinations Have any contraindications to MRI such as a pace-maker, magnetic material i.e., surgical clips or any other conditions that would preclude proximity to a strong magnetic field. Are suffering from severe claustrophobia. Have 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.