Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients
Status: | Completed |
---|---|
Conditions: | Brain Cancer, Brain Cancer, Neurology |
Therapuetic Areas: | Neurology, Oncology |
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 7/20/2018 |
Start Date: | May 18, 2017 |
End Date: | March 16, 2018 |
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)
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.
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.
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.
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.
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).
We found this trial at
1
site
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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