Clinical trial NCT00907530: Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain
Official title: Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Lesions
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.


Eligibility criteria: 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) (primary or secondary), as determined by:
* clinical/neurological symptomatology;
* diagnostic testing, such as CT or previous MRI examinations; or
* have had recent surgery within 6 months and are to be evaluated for recurrence.

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 bHCG) within 24 h prior to the start of each investigational product administration
* by history (i.e., tubal ligation or hysterectomy)
* post menopausal with a minimum of 1 year without menses
* Have any known allergy to one or more of the ingredients in the investigational product, 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 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h 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 h post-administration of the second investigational product.
* Have moderate-to-severe renal impairment, defined as a GFR/eGFR \< 60 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
* 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

Primary outcomes:
measure: To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
timeFrame: Day 1 and Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
Study officials:
affiliation: Bracco Diagnostics
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References: