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

NCT ID: NCT03147989

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 352 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2018-03-16

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.

Conditions

Central Nervous System Diseases; Central Nervous System Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

MultiHance

Intervention Type: DRUG

gadolinium contrast agent

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.

MultiHance

Intervention Type: DRUG

gadolinium contrast agent

Interventions

MultiHance

gadolinium contrast agent

Intervention Type: DRUG

Other Intervention Names

Gadobenate Dimeglumine

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.

• 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).

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianpaolo Priovano, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

Sarasota Memorial Hospital

Sarasota, Florida, United States

Countries

United States

Other Identifiers

MH-151

Identifier Type: -

Identifier Source: org_study_id