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
Sponsored by Bayer
About this trial
Last updated a year ago
Study ID
22072
Status
Completed
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial 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.
What are the participation requirements?
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