Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Multihance

Magnevist

Gianpaolo Pirovano, MD

To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Multihance Versus Magnevist in Breast MRI

Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast

Bracco Diagnostics, Inc

Gianpaolo Pirovano, M.D., Executive Director, Corporate Medical Development

Nervous System Diseases

Central Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

For patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg for their clinically indicated MRI examination.

For patients having received MULTIHANCE at a dose of 0.05 mmol/kg for their clinically indicated MRI examination.

MultiHance

Gianpaolo Priovano, MD

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.

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.

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)

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

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

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

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.

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

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

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

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

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Subjects having a clinically ordered MRI with Eovist. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the can. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

Subjects having a clinically ordered MRI with Multihance. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the scan. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

Patients will have Multihance used as an IV contrast agent for their scan.

MRI with Multihance

Patients will have Eovist used as an IV contrast agent for their scan.

MRI with Eovist

Matthew Davenport, MD

The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).

Contrast-enhanced hepatic MRI is an accepted method for detecting and characterizing liver lesions. Liver lesion characterization is fundamental for patient management, because lesions that meet specific imaging criteria for hepatocellular carcinoma (HCC) are assumed to be HCC without tissue confirmation. There are a variety of gadolinium-based contrast agents that are used for this purpose. Two of the more commonly utilized are gadoxetic acid (an hepatobiliary contrast agent that permits 20 minute hepatobiliary phase imaging) and gadobenate dimeglumine (a weak hepatobiliary contrast agent that functions generally as an extracellular contrast agent). A recent study by our group has shown that patients who receive intravenous gadoxetic acid are much more likely to experience transient dyspnea after contrast injection that causes them to breathe rapidly through the arterial phase of imaging, degrading image quality. In that study, subjective complaints of dyspnea and respiratory motion artifact on imaging were scored. The investigators did not assess patient physiologic response. The goal of the proposed work is to build on our prior data and to determine whether there are non-invasively measurable physiologic parameters that can support our original study. Specifically, the investigators want to determine whether there are predictable changes in SpO2, pulse, respiratory periodicity, and respiratory regularity that correlate with arterial phase image degradation and patients complains of dyspnea. Both contrast agents to be assessed in this study are FDA approved with at least 4 years of post-marketing experience documenting safety and efficacy. The investigators will not be changing or altering our clinical approach in any way as a part of this study.

Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.

We will monitor a subjects' oxygen levels by placing a small monitor on one of their fingers before and after the MRI; lasting approximately one minute each.

We will monitor a subjects' respiratory rate (how many times they breathe in a minute) during the clinical MRI scan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multihance Versus Magnevist in Breast MRI	NCT00486473	Breast Cancer	Multihance Magnevist	18 Years -	Bracco Diagnostics, Inc
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients	NCT03147989	Central Nervous... Central Nervous...	MultiHance	2 Years -	Bracco Diagnostics, Inc
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients	NCT03147989	Central Nervous... Central Nervous...	MultiHance	2 Years -	Bracco Diagnostics, Inc
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients	NCT03147989	Central Nervous... Central Nervous...	MultiHance	2 Years -	Bracco Diagnostics, Inc
Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration	NCT02226666	Liver Tumor	MRI with Multih... MRI with Eovist	18 Years -	University of Michigan

Spots Global Cancer Trial Database for multihance

Every month we try and update this database with for multihance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for multihance

Every month we try and update this database with for multihance cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for multihance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.