Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

Completed · Phase 4

Conditions studied: Brain Disease

In brief

This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Key facts

Study ID

NCT01613417

Run by

Bracco Diagnostics, Inc

People needed

229

Starts

2012-08-01

Expected to finish

2014-04-01

Last updated by the study team

2015-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are scheduled to undergo MRI
• Are willing to undergo two MRI procedures within 14 days
• Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
• Clinical/neurological symptomatology;
• Diagnostic testing, such as CT or previous MRI examinations; or
• Have had previous brain surgery and are to be evaluated for recurrence.

You may not qualify if…

• 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 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; see Appendix A)
• 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 or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product.
• Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 45 mL/min.
• 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

Where it is running

• Holy Name Medical Center — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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