Clinical trial NCT02070380: Crossover Comparison of MultiHance and Dotarem
Official title: Phase IV, Double Blind, Multi-Center, Randomized, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Disease
Keywords: confirmed brain disease
highly suspected brain disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 179
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 aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Detailed description: This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.

Eligibility criteria: 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 brain surgery and are to be evaluated for recurrence

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 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 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 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 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: Global Diagnostic Preference Between the Two Exams
timeFrame: Comparison of image sets obtained within 2 to 14 days
Secondary outcomes:
measure: Lesion Border Delineation
timeFrame: Comparison of image sets obtained within 2 to 14 days
measure: Lesion Internal Morphology
timeFrame: Comparison of image sets obtained within 2 to 14 days
measure: Extent of Disease
timeFrame: Comparison of image sets obtained within 2 to 14 days
measure: Lesion Contrast Enhancement
timeFrame: Comparison of image sets obtained within 2 to 14 days
measure: Lesion to Background Ratio on Post T1-weighed Spin Echo Images
timeFrame: 5-10 minutes Postdose
measure: Lesion-brain Contrast-to-noise Ratio
timeFrame: 5-10 minutes Postdose
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Samaritan Health Services
state: Oregon
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References: