Gadobutrol (Gadavist/Gadovist, BAY86-4875)
DrugAt discretion of attending physician
NCT Number: NCT05350189
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.
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Observational
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At discretion of attending physician
Time frame: Up to 12 weeks
Wastage will be defined as:
For single-dose vials, any unused product that remains immediately following the administration of Gadavist to a single patient.
Time frame: Up to 12 weeks
Wastage will be defined as:
For IBPs, any unused product that remains after the administration of Gadavist to some number of patients and where the allowable 24-hour window has expired, or in the event of office closure, would expire before the next scheduled Gadavist-enhanced MRI. Should a patient receive Gadavist via a single-dose vial due to insufficient product remaining in an IBP during the IBP cohort, the wastage from this single-dose vial will contribute to the overall wastage of that IBP.
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Bayer
Industry
GUS: Gadavist Drug Utilization Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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