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Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients

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ClinicalTrials.gov Identifier: NCT03147989
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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.

Condition or disease Intervention/treatment
Central Nervous System Diseases Central Nervous System Neoplasms Drug: MultiHance

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.


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Study Type : Observational
Actual Enrollment : 352 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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)
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine


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.
Drug: MultiHance
gadolinium contrast agent
Other Name: Gadobenate Dimeglumine

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.
Drug: MultiHance
gadolinium contrast agent
Other Name: Gadobenate Dimeglumine




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147989


Locations
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United States, Florida
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Gianpaolo Priovano, MD Bracco Diagnostics, Inc

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT03147989     History of Changes
Other Study ID Numbers: MH-151
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bracco Diagnostics, Inc:
MultiHance
MRI
CNS
Gadobenate Dimeglumine

Additional relevant MeSH terms:
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Nervous System Diseases
Central Nervous System Diseases
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms