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

Completed

Conditions studied: Central Nervous System Diseases, Central Nervous System Neoplasms

In brief

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.

Key facts

Study ID

NCT03147989

Run by

Bracco Diagnostics, Inc

People needed

352

Starts

2017-05-18

Expected to finish

2018-03-16

Last updated by the study team

2018-07-18

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Sarasota Memorial Hospital — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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