Clinical trial NCT03147989: Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients
Official title: A Parallel-Group Comparison of Two Doses Of Multihance (0.10 mmol/Kg and 0.05 mmol/Kg) When Used For Magnetic Resonance Imaging (MRI) of The Central Nervous System (CNS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Diseases
Central Nervous System Neoplasms
Keywords: MultiHance
MRI
CNS
Gadobenate Dimeglumine
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 352
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 2 years of age, having had a Multihance administration with either a dose of 0.10 mmol/kg or a dose of 0.05 mmol/kg for MRI of the CNS for a suspected or known extra-axial tumor at 1.5T, or suspected or known CNS disease at 3.0T.

Brief summary: This is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will be prospectively reviewed in a blinded read to compare the efficacy of the two doses.

Detailed description: This study is retrospective in design in that the MR images and other patient data, such as demographic data, will be collected from existing data for the selected patients meeting the inclusion criteria defined in this protocol. The study will be a multicenter study comparing interindividually two groups, one group of patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg and the other group a dose of 0.05 mmol/kg for their clinically indicated MRI examination.

In order to minimize selection bias, recruitment will start with the "Final Date" of this protocol and, working backward chronologically from all the MR examinations stored in the local site Picture Archiving and Communication Systems (PACS), every patient meeting the inclusion criteria will be recruited for the study until the total number of patients (160) in each group will be reached.

The images of all included patients will be prospectively reviewed in a blinded read.

Eligibility criteria: Inclusion Criteria:

* Was at least 2 years of age at the time of the MRI with MULTIHANCE injection at the dose of either 0.1 or 0.05 mmol/kg (±20% in volume administered).
* Has available demographic and safety data.
* Belongs to one of these 4 sub-groups:

  1. Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE.
  2. Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE.
  3. Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE.
  4. Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE.
* Have both pre- and post-dose T1 SE/FSE, and/or GRE, and T2 SE/FSE, and FLAIR MR Images (when available).
* Has one of the two documented doses of MULTIHANCE (either 0.05 or 0.1 mmol/kg) administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose (mmol/kg) of MULTIHANCE that was administered.

Exclusion Criteria:

* Any patient who does not fulfill all of the inclusion criteria;
* Any patient who has been previously entered into this study. Patients must be enrolled only once into the study. Working backward chronologically from date of the final Protocol, if a patient has already been enrolled and appears in the PACs System again due to an earlier MRI, this patient must be excluded from the study (i.e., only the first qualifying MRI working backward chronologically from the date of the final Protocol should be included into the study).

Primary outcomes:
measure: Non-inferiority in border delineation of lesions
timeFrame: 1 Day
measure: Non-inferiority in visualization of internal morphology of lesions
timeFrame: 1 Day
measure: Non-inferiority in contrast enhancement of lesions
timeFrame: 1 Day
Secondary outcomes:
measure: Comparison of patient level change in border delineation of lesions
timeFrame: 1 Day
measure: Comparison of patient level change in visualization of internal morphology of lesions
timeFrame: 1 Day
measure: Comparison of patient level change in contrast enhancement of lesions
timeFrame: 1 Day
measure: Comparison of Lesion-to-brain ratio
timeFrame: 1 Day
measure: Comparison of contrast-to-noise ratio
timeFrame: 1 Day
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Priovano, MD
role: STUDY_DIRECTOR
References: