A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting

Bayer

Status: Completed

Conditions: Contrast Enhancement in Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Study type: Observational

Funder types: Industry

Identifiers

NCT05350189

22072

Details and patient eligibility

About

This is an observational study, in which data associated with the wastage with the use of Gadavist single-dose vials, as compared to the wastage associated with the use of the Gadavist imaging bulk packages (IBP) used for contrast-enhanced magnetic resonance imaging (MRI) using Gadavist will be compared.

MRI is a medical technique, which creates detailed images of the organs, soft tissues and structures inside the body. Combination of MRI with a "dye" that is injected into the vein (called contrast media, like Gadavist) creates what is called a contrast-enhanced MRI that enables clearer pictures of the body and helps doctors to see problems better than an MRI without contrast media.

The drug Gadavist (also called gadobutrol) is a gadolinium-based contrast media for diagnostic use in MRI, which is given as an injection into the vein to improve the quality of the MRI pictures. Gadavist is already approved for several indications including imaging of brain and spinal cord, breast imaging, imaging of blood vessels, and diagnoses of heart disease. It helps doctors for example to detect:

• areas with disrupted blood brain barrier (BBB), which is crucial to protect the brain from toxic components and pathogens (germs, viruses, disease-causing agents)
• abnormal blood vessels in certain blood vessels
• presence and size of breast cancer
• heart disease The dosing of Gadavist is weight-based and currently available in single-use vials, which are associated with wastage. To reduce wastage and wastage associated costs, multi-dose vials, also called imaging bulk packages (IBP) were developed, which are already approved in the USA since January 2021.

The aim of this study is to understand how much of the contrast agent Gadavist is used and how much is wasted in two different containers (single-dose vials and Imaging Bulk Packages (IBP)) in a real-world setting. To do this, researchers will review information collected regarding the amount of Gadavist used for patients undergoing contrast-enhanced MRI for any indication regarding:

• vial type (single-dose or IBP)
• size of single-dose or IBP
• volume of administered dose (mL)
• date of administration
• time of administration
• injection modality (manual vs power)
• type of power injector, if applicable

There will be no study-mandated visits or treatments. The decision to undergo a contrast-enhanced MRI with Gadavist will be made by the study participants with their doctors before data collection, and independently of this study. Data will be collected over a period of approximately 6-weeks, until the data collection of 1200 participants for each comparison group (vial type) is completed. No patient information beyond Gadavist dose will be collected in this study.

Enrollment: 1,602 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• A contrast-enhanced MRI using Gadavist for any indication at the study site during the study period
• Scheduled MRI to be performed in a study-designated room

Exclusion criteria

• Administration of Gadavist from a single-dose prefilled syringe
• MRIs performed in the emergency setting

Trial design

1,602 participants in 2 patient groups

Gadavist Single-dose vial

Description:

Data will be collected from contrast-enhanced Magnetic Resonance Imaging (MRI) using Gadavist from a single-dose vial of 7.5 or 10 or 15 milliliters (mL).

Treatment:

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Gadavist IBP

Description:

Data will be collected from contrast-enhanced MRI using Gadavist from an IBP of either 30 or 65 milliliters (mL), and from Gadavist via a single-dose vial due to insufficient product remaining in an IBP during the IBP cohort.

Treatment:

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)