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

NCT03147989 | Completed

• 1 other identifier: MH-151
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Diseases; Central Nervous System Neoplasms

Keywords

MultiHance; MRI; CNS; Gadobenate Dimeglumine

Outcome Measures

Primary Outcomes (3)

• Non-inferiority in border delineation of lesions

  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

  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

  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 Outcomes (5)

• Comparison of patient level change in border delineation of lesions

  1 Day

• Comparison of patient level change in visualization of internal morphology of lesions

  1 Day

• Comparison of patient level change in contrast enhancement of lesions

  1 Day

• Comparison of Lesion-to-brain ratio

  1 Day

• Comparison of contrast-to-noise ratio

  1 Day

Study Arms (2)

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

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

Interventions

MultiHance DRUG

gadolinium contrast agent

Also known as: Gadobenate Dimeglumine

Group 1, 0.10 mmol/kg; Group 2, 0.05 mmol/kg

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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 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).

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

MeSH Terms

Conditions

Central Nervous System Diseases; Central Nervous System Neoplasms

Interventions

gadobenic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Gianpaolo Priovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 10, 2017
• Study Start: May 18, 2017
• Primary Completion: December 7, 2017
• Study Completion: March 16, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)