Phase
Condition
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 protocolrequirements
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) (primary or secondary),as determined by:
Clinical/neurological symptomatology;
Diagnostic testing, such as CT or previous MRI examinations; or
Have had recent brain surgery and are to be evaluated for recurrence
Exclusion
Exclusion Criteria:
Are pregnant or lactating females. Exclude the possibility of pregnancy:
By testing on site at the institution within 24 hours prior to the start of eachinvestigational 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 investigationalproducts, or have a history of hypersensitivity to any metals
Have congestive heart failure (class IV according to the classification of the NewYork Heart Association)
Have suffered a stroke within a year
Have received or are scheduled to receive any other contrast medium in the 24 hourspreceding through the 24 hours following Exam 1, and in the 24 hours preceding throughthe 24 hours following Exam 2
Have received or are scheduled to receive an investigational compound and/or medicaldevice within 30 days before admission into the present study, through the 24 hourspost-administration of the second investigational product
Have moderate-to-severe renal impairment, defined as Glomerular Filtration Rate (GFR)/estimated GFR < 45 mL/min
Have been previously entered into this study
Have received or are scheduled for one of the following:
Surgical or chemotherapeutic treatment within three weeks prior to the firstexamination 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 strongmagnetic field
Are suffering from severe claustrophobia
Have any medical condition or other circumstances which would significantly decreasethe chances of obtaining reliable data, achieving study objectives, or completing thestudy and/or post-dose follow-up examinations
Study Design
Study Description
Connect with a study center
Samaritan Health Services
Corvallis, Oregon 97330
United StatesSite Not Available
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