Clinical trial NCT01613417: Comparison of Prohance® With Gadovist®/Gadavist™ 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 Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Disease
Keywords: Have confirmed or are highly suspected of brain disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 229
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 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.

Detailed description: Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

Eligibility criteria: Inclusion Criteria:

* 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.

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; 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

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: Percentage Signal Intensity Enhancement on Postdose Images
timeFrame: 5-10 minutes Postdose
measure: Lesion Detection
timeFrame: 5-10 minutes Postdose
measure: Accuracy for Tumor Characterization
timeFrame: 5-10 minutes Postdose
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References:
citation: Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Zizka J, Colosimo C, Urbanczyk-Zawadzka M, Mechl M, Bag AK, Bastianello S, Bueltmann E, Hirai T, Frattini T, Kirchin MA, Pirovano G. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015 Jan;36(1):14-23. doi: 10.3174/ajnr.A4154. Epub 2014 Oct 9.