- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147989
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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.
- 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.
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1, 0.10 mmol/kg
For patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg for their clinically indicated MRI examination.
|
gadolinium contrast agent
Other Names:
|
Group 2, 0.05 mmol/kg
For patients having received MULTIHANCE at a dose of 0.05 mmol/kg for their clinically indicated MRI examination.
|
gadolinium contrast agent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-inferiority in border delineation of lesions
Time Frame: 1 Day
|
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: Border delineation of lesions
|
1 Day
|
Non-inferiority in visualization of internal morphology of lesions
Time Frame: 1 Day
|
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: visualization of internal morphology of lesions
|
1 Day
|
Non-inferiority in contrast enhancement of lesions
Time Frame: 1 Day
|
To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: contrast enhancement of lesions
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of patient level change in border delineation of lesions
Time Frame: 1 Day
|
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/ kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to border delineation of lesions.
|
1 Day
|
Comparison of patient level change in visualization of internal morphology of lesions
Time Frame: 1 Day
|
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to visualization of internal morphology of lesions
|
1 Day
|
Comparison of patient level change in contrast enhancement of lesions
Time Frame: 1 Day
|
To compare the efficacy of MULTIHANCE in MRI of the CNS in patients at a dose of 0.10 mmol/kg and 0.05 mmol/kg in terms of patient level changes from pre-dose to pre + post-dose, with regard to contrast enhancement of lesions
|
1 Day
|
Comparison of Lesion-to-brain ratio
Time Frame: 1 Day
|
To compare the two doses of MultiHance in terms of predose to postdose by lesion changes for up to the 3 largest lesions in Lesion-to-brain ratio
|
1 Day
|
Comparison of contrast-to-noise ratio
Time Frame: 1 Day
|
To compare the two doses of MultiHance in terms of predose to postdose by lesion changes for up to the 3 largest lesions in Contrast-to-noise ratio
|
1 Day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gianpaolo Priovano, MD, Bracco Diagnostics, Inc
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH-151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Central Nervous System Diseases
-
Bracco Diagnostics, IncCompletedCentral Nervous System Neoplasms | Central Nervous System Disease
-
Weill Medical College of Cornell UniversityRecruitingCentral Nervous System Tumor | Pediatric Central Nervous System TumorUnited States
-
Bracco Diagnostics, IncCompletedCentral Nervous System Diseases | Central Nervous System NeoplasmsUnited States
-
Washington University School of MedicineRecruitingCentral Nervous SystemUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingCentral Nervous System TumorUnited States
-
Washington University School of MedicineLloyd J. Old STAR ProgramTerminatedCentral Nervous System Neoplasms | Central Nervous System TumorUnited States
-
Children's Oncology GroupRecruitingCentral Nervous System CarcinomaUnited States, Puerto Rico
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknown
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingCentral Nervous System Tumor | Somatic Mutation | Pediatric Central Nervous System Tumor | Discordant TwinUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingMalignant Central Nervous System NeoplasmUnited States
Clinical Trials on MultiHance
-
Bracco Diagnostics, IncCompletedA Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain (ENHANCE)Brain PathologyUnited States
-
Bracco Diagnostics, IncCompleted
-
Bracco Diagnostics, IncCompletedCentral Nervous System PathologyPoland
-
Bracco Diagnostics, IncCompletedPeripheral Vascular DiseaseItaly
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bracco Diagnostics, IncCompletedHepatocellular CarcinomaUnited States
-
Bracco Diagnostics, IncCompletedSteno-occlusive DiseaseItaly
-
Bracco Diagnostics, IncCompleted
-
Bracco Diagnostics, IncTerminatedCentral Nervous System DiseasesUnited States
-
Bracco Diagnostics, IncCompletedCentral Nervous System Neoplasms | Central Nervous System Disease
-
Technical University of MunichCompletedSubacute/Chronic Myocardial InfarctionGermany